CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
FDA Recall Z-1534-2014 · Posted 2014-05-01
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeNEW
Date Initiated2014-03-11
Date Terminated2016-03-29
Product Quantity7,380 ea (total)
Reason for Recall
The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
Firm Action
Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 11, 2014. The letter identified the affected product, problem and actions to be taken. Custmers were instructed to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990
Root Cause
Other
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.
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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