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cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
potential for metal in product
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Mislabeled: Product may contain undeclared sesame seeds
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Undeclared pine nut
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Product is missing the ingredient list (which lead to missing wheat and Yellow No. 6), and a nutritional panel.