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.
Reported: April 2, 2014 Initiated: March 11, 2014 #Z-1294-2014
Product Description
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.
Reason for Recall
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- Total 32,271 ea.
- Distribution
- Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teleflex Medical. Units affected: Total 32,271 ea..
Why was this product recalled? ▼
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 2, 2014. Severity: Moderate. Recall number: Z-1294-2014.
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