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Teleflex Medical recalls Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, R
Recalled May 14, 2014 · FDA recall Z-1558-2014 · Teleflex Medical
Hazard
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. · FDA Class II
Units
32,271 ea.
Sold at
Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
Description
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Product
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →