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Ethicon, Inc. recalls PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

Recalled July 25, 2018 · FDA recall Z-2455-2018 · 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
432
Sold at
Accounts in AZ, CA, CO, FL, GA, IL, IN, KS, MA, MN, MO, NC, NE, NJ, NY, OH, OR, SC, SD, TN, TX, VA, WA, WI, WV.

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 30"(75CM) 8-0 BLUE, D8292
Manufacturer(s)
Ethicon, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Ethicon, Inc. recalls PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292 | RecallWatchUSA