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Ethicon, Inc. recalls PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
Recalled July 25, 2018 · FDA recall Z-2449-2018 · 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
1728
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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
PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
Manufacturer(s)
Ethicon, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →