Class I - Dangerous
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)
Pro-Med Instruments Gmbh
Class I - Dangerous
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
Apo B Reagent, REF: OSR6143
Beckman Coulter Ireland
Class I - Dangerous
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Class I - Dangerous
Potential for breach of Tyvek seals.
ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Class I - Dangerous
Potential for breach of Tyvek seals.
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Ortho-Clinical Diagnostics
Class I - Dangerous
Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
BioFire Diagnostics
Class I - Dangerous
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Class I - Dangerous
Potential for breach of Tyvek seals.
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Maquet Cardiopulmonary Ag
Class I - Dangerous
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Cardinal Health 200
Class I - Dangerous
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Ultra Clean Systems
Class I - Dangerous
During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation.