FDAFDA · Food and drugs·Recall number Z-1294-2014
Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.
Published April 2, 2014 · Recall initiated: March 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The products are being recalled because they did not meet minimum needle attachment strength requirements.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
- Lot
- Product Code: BON100, Lot numbers: 02H1302839, 02J1101705, 02D1101137, and 02F1103013.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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