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Ethicon, Inc. recalls PRONOVA SUTURE BLUE 122CM M1.5, D10189
Recalled July 25, 2018 · FDA recall Z-2466-2018 · Ethicon
Hazard
The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. · FDA Class II
Units
516
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Description
The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.
Product
PRONOVA SUTURE BLUE 122CM M1.5, D10189
Manufacturer(s)
Ethicon, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →