medical Class II Updated 2018-07-25

Ethicon, Inc. recalls PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

Recalled Product

PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

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: KGJ667 KJJ690 KMH714 KPP499 LBJ528 LCJ143 LPJ095 MDH288
View official government recall

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