Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.
FDA Recall Z-1497-2014 · Posted 2014-04-24
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeGAQ
Date Initiated2014-03-11
Date Terminated2015-12-17
Product Quantity3,816 ea
Reason for Recall
The products are being recalled because they did not meet minimum diameter requirements.
Firm Action
Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected constomers. The letter identified the affected product, problem and actions to be taken. Customers were instructed if they have affected stock immediately discontinue use, quarantine, and return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgement Form and Fax it to 1-508-964-6078, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-508-964-6042.
Root Cause
Other
Distribution Pattern
Worldwide Distribution - CA, CO, FL, IN, KY, MA, NM, PA, Canada, Ireland and Germany.
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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