Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes. The products are labeled in parts. These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.
FDA Recall Z-3177-2011 · Posted 2011-09-09
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Recalling FirmC P Medical Inc.
Recall StatusTerminated
Product CodeGAR
Date Initiated2011-06-29
Date Terminated2012-05-24
Product Quantity776 dozens boxes
Reason for Recall
Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material.
Firm Action
CP Medical sent a "RECALL NOTICE" letter dated June 29, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.
The letter instructs customers to discontinue use of the affected products in the human market and to return all their existing stock. A Recall Checklist was enclosed for customers to complete and return.
Contact Customer Service at 1-800-950-2763 for a Return Good Authorization and shipping account number. The firm will pay for shipping cost and replace product at no cost to customers.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Italy, Romania, South Africa, and Taiwan.
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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