Ethicon, Inc. recalls PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647

Recall date

May 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2456-2018

FDA classification

Class II

Brand / firm

Ethicon, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647