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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description Monoswift® PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek® pouch. It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric), PS-1 Needle
Recall Number Z-1708-2014
Classification Class II
Code Info Lot 130826-08, expiration 2015-07.
Product Distributed Qty US distribution:4 boxes/ 12 sutures per box (48 total); Outside US: 44 boxes/12 sutures per box. (528 total).
Reason For Recall CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength.

Event Detail

Event Id 68153
Product Type Devices
Status Ongoing
Recalling Firm C P Medical Inc.
City Portland
State OR
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-23
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - US Nationwide
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