FDAClass IIMay 14, 2014

Deknatel Teleflex Medical Stainless Steel 2 recall

Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of…

Why was Deknatel Teleflex Medical Stainless Steel 2 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 X-4981M4 - Lot 02J0800451

Product
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of…
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)
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