Bard Fixt Suture Braided Polyester recall
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue…
Why was Bard Fixt Suture Braided Polyester recalled?
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code H5300 - Lot 1450153E13
- Product
- Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue…
- Recalling firm
- Teleflex Medical
- Quantity
- 32,271 ea.
- Distribution
- 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.
- Recall date
- May 14, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)