medical Class II Updated 2018-07-25

Ethicon, Inc. recalls PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

Recalled Product

PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

Hazard / Issue

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.

Issued by

FDA

Affected States: 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
Lot/Code Info: LCJ948 MCQ529
View official government recall

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