FDAFDA · Food and drugs·Recall number Z-0487-2025
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 neurological tissues, microsurgery or ophthalmic surgery.
Published November 27, 2024 · Recall initiated: October 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ETHICON, INC.
- Distributor
- 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.
- Lot
- Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Mexico
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