Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.
FDA Recall Z-1557-2014 · Posted 2014-05-07
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeGAQ
Date Initiated2014-03-11
Date Terminated2017-08-14
Product Quantity32,271 ea.
Reason for Recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Firm Action
Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.
Root Cause
Employee error
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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