Bard Peripheral Vascular SAFE-T PLUS ATRAUMATIC ADULT LP TRAY recall — FDA Z-0800-2022
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these…
Sterility of device is compromised due to a sterile barrier breach
Sterility of device is compromised due to a sterile barrier breach
Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the…
Sterility of device is compromised due to a sterile barrier breach
LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This…
Sterility of device is compromised due to a sterile barrier breach
Hazelnuts were declared in ingredient statement but not in Contains statement.
Undeclared wheat.
Undeclared allergen - egg
Undeclared wheat.
Undeclared wheat.
Undeclared wheat.
Undeclared wheat.
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
Incorrect packaging for product resulting in an undeclared wheat allergen
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
Undeclared almonds
During manufacturing pieces of hard clear plastic was found. Upon investigation the source was identified as ice purchased from supplier.
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