ETHICON, INC.: MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurol

Hazard

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

Details from the source

Reason for recall: Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length. Distribution: U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Not provided. Quantity: 16,524 devices Lot/code info: Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD

UPC codes

10705031059917

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.