Teleflex Medical recalls Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a no

Recalled April 2, 2014 · FDA recall Z-1296-2014 · Teleflex Medical

Hazard

The products are being recalled because they did not meet minimum needle attachment strength requirements. · FDA Class II

Units

Total 32,271 ea.

Sold at

Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

Description

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Product

Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

Manufacturer(s)

Teleflex Medical

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →