FDA-Device2014-04-02Class II
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.
Teleflex Medical
Hazard
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Sold states
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Affected count
Total 32,271 ea.
Manufactured in
2917 Weck Dr., N/A, Research Triangle Park, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2014Don't want to check this manually?
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