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The firm had a positive Listeria Monocytogenes on a sample from this batch of product made.
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.
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.