Stryker Sustainability Solutions Class II
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Powód: Reusable access port system may crack or seperate during use.
Narzędzie · wycofania
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Przeszukaj aktualne wycofania wyrobów medycznych zgłoszone do amerykańskiej FDA — według nazwy producenta, wyrobu lub przyczyny. Dane są przydatne przy sprawdzaniu dostawcy przed importem z USA i wskazują typowe przyczyny wycofań.
80 ostatnich wycofań (źródło: openFDA, USA)
Datex-Ohmeda, Inc. Class II
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Powód: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled
Datex-Ohmeda, Inc. Class II
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665
Powód: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled
AVID Medical, Inc. Class I
Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;
Powód: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Medline Industries, LP Class I
Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
Powód: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products
GE Medical Systems Information Technologies Inc Class II
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV
Powód: Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
Nova Biomedical Corporation Class I
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
Powód: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality
ICU Medical, Inc. Class II
Oncology sets with drip chambers
Powód: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path,
Datex-Ohmeda, Inc. Class II
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Powód: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled
ICU Medical, Inc. Class II
Oncology sets with drip chambers
Powód: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path,
Medline Industries, LP Class II
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Powód: The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannu
ICU Medical, Inc. Class II
IV Sets with drip chambers
Powód: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and
Happiest Baby, Inc Class II
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Powód: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
GE Healthcare Class II
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
Powód: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t
Abiomed, Inc. Class I
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code:
Powód: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
AVID Medical, Inc. Class I
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
Powód: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Nova Biomedical Corporation Class I
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
Powód: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality
Nova Biomedical Corporation Class I
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
Powód: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality
ICU Medical, Inc. Class II
Plum administration sets
Powód: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and
ICU Medical, Inc. Class II
IV Sets with drip chambers
Powód: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and
Philips North America Class II
Philips PIC iX Essentials REF:867093
Powód: Due to software malfunction, patient information system may freeze and become unresponsive.
Medline Industries, LP Class I
Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
Powód: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products
Howmedica Osteonics Corp. Class II
SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
F & A Foundation Class II
Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-40907; 11mm x 10m
Powód: Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
Stryker Sustainability Solutions Class II
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Powód: Reusable access port system may crack or seperate during use.
Mirion Technologies (Capintec), Inc. Class II
Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Powód: Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.
Howmedica Osteonics Corp. Class II
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
Howmedica Osteonics Corp. Class II
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
Stryker Sustainability Solutions Class II
REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
Powód: Reusable access port system may crack or seperate during use.
GE Healthcare Class II
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from
Powód: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t
PI CARDIA LTD Class II
Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
Powód: Transfemoral catheter, positing arm may detached due to weld issue.
Bayer Medical Care, Inc. Class II
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Powód: Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Wilson-Cook Medical Inc. Class II
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endo
Powód: Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
Maquet Cardiopulmonary Gmbh Class II
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Powód: The packaging may not consistently maintain sterile barrier integrity.
Abiomed, Inc. Class I
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Produc
Powód: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Medline Industries, LP Class I
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
Powód: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products
Howmedica Osteonics Corp. Class II
OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
Howmedica Osteonics Corp. Class II
TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
ICU Medical, Inc. Class II
IV Non-Dedicated Gravity Administration Sets with drip chambers
Powód: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path,
GE Healthcare Class II
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
Powód: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t
Medline Industries, LP Class I
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON STERILE CHEST TUBE REMOVAL, Catalog Number: DYNDA1080
Powód: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products
Medline Industries, LP Class I
Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number: DYNDH1619A; 4) DYNDH1620A, Catalog Number: DYNDH1620A; 5) DYNDH1694A, Catal
Powód: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products
Boston Scientific Corporation Class II
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300
Powód: A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.
Abiomed, Inc. Class I
Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-00
Powód: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
Maquet Cardiopulmonary Gmbh Class II
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Powód: The packaging may not consistently maintain sterile barrier integrity.
AVID Medical, Inc. Class I
Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
Powód: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Medline Industries, LP Class II
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Powód: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
ICU Medical, Inc. Class II
IV Sets with drip chambers
Powód: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and
NOXBOX LTD Class II
NOxBOXi Nitric Oxide Delivery System.
Powód: Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
PTW FREIBURG Class II
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
Powód: When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescr
Medline Industries, LP Class II
Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
Powód: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Happiest Baby, Inc Class II
Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534 S2101-535 S2101-536
Powód: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Stryker Sustainability Solutions Class II
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Powód: Reusable access port system may crack or seperate during use.
Howmedica Osteonics Corp. Class II
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORP
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
Howmedica Osteonics Corp. Class II
DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 536
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
Medline Industries, LP Class I
Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Number: ACC010679; 4) ACC010726A, Catalog Number: ACC010726A; 5) DYNDB3061, C
Powód: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products
Bard Access Systems, Inc. Class I
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605240; Power-Tr
Powód: this is a downstream recall of class I recall RES 98777
Howmedica Osteonics Corp. Class II
SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
ICU Medical, Inc. Class II
IV Sets with drip chambers
Powód: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and
AVID Medical, Inc. Class I
Halyard IV START KIT NON-STERILE REF: KRIV26-02
Powód: Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
GE Healthcare Class II
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
Powód: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t
Nova Biomedical Corporation Class I
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Powód: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality
Howmedica Osteonics Corp. Class II
BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
embecta Medical II LLC Class II
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
Powód: Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.
Straumann USA LLC Class II
GM Helix Implant, REF: 109.984;
Powód: There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
WELL LEAD MEDICAL CO. LTD Class II
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Powód: The 6Fr suction catheter could not pass through the samples smoothly.
BD SWITZERLAND SARL Class I
BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Se
Powód: Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Howmedica Osteonics Corp. Class II
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
GE Healthcare Class II
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
Powód: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t
Stryker Sustainability Solutions Class II
REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
Powód: Reusable access port system may crack or seperate during use.
Philips North America Class II
Philips Patient Information Center iX REF:866389
Powód: Due to software malfunction, patient information system may freeze and become unresponsive.
GE Healthcare Class II
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
Powód: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead t
Nova Biomedical Corporation Class I
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Powód: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality
Medline Industries, LP Class II
Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
Powód: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Howmedica Osteonics Corp. Class II
TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
Medline Industries, LP Class I
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F
Powód: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products
AVID Medical, Inc. Class I
Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
Powód: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
restor3d Inc. Class II
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Powód: Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migra
Datex-Ohmeda, Inc. Class II
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Powód: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled
Howmedica Osteonics Corp. Class II
AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Powód: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to
Komentarz eksperta · MEDDEV
Wnioski z wycofań dla producentów i importerów
W danych o wycofaniach powtarza się ten sam obraz: rzadko zawodzi sama technologia wyrobu. Najczęstsze przyczyny to błędy w etykietowaniu i instrukcji używania, wady oprogramowania, problemy ze sterylnością lub pakowaniem oraz niespójności w dokumentacji i identyfikacji partii. Są to problemy regulacyjne, nie tylko „awarie sprzętu”, dlatego wielu z nich można uniknąć.
Klasa wycofania (Class I, II, III w nomenklaturze FDA) określa powagę zagrożenia, nie klasę ryzyka wyrobu. Class I oznacza realne ryzyko poważnego uszczerbku na zdrowiu — i to tam najczęściej w tle leży niedoszacowane ryzyko albo luka w nadzorze posprzedażowym.
Dla importera wniosek jest praktyczny: przed wprowadzeniem wyrobu spoza UE należy sprawdzić historię producenta. Wpis na liście wycofań FDA nie przesądza o sytuacji w UE, ale jest sygnałem ostrzegawczym — wskazuje, gdzie szukać słabych punktów w dokumentacji i procesach. Dla producenta to z kolei mapa najczęstszych potknięć, które wymagają kontroli w dokumentacji technicznej, zarządzaniu ryzykiem i planie PMS.
Większości tych wycofań dałoby się uniknąć rzetelną oceną ryzyka (EN ISO 14971), spójną dokumentacją i działającym nadzorem po wprowadzeniu do obrotu. Przed wejściem na rynek warto sprawdzić właśnie te obszary: ocenę ryzyka, kompletność dokumentacji i działający nadzór po wprowadzeniu do obrotu.
Audyt zerowy
Ryzyko wyrobu przed wejściem na rynek
Weryfikacji podlegają dokumentacja, ocena ryzyka i nadzór posprzedażowy — czyli obszary, które najczęściej stoją za wycofaniami.