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Teleflex Medical recalls Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. In
Recalled May 14, 2014 · FDA recall Z-1559-2014 · 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
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →