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U.S. Department of Health and Human Services

Class 2 Device Recall Monoswift

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 Class 2 Recall
Monoswift
see related information
Date Posted June 03, 2014
Recall Status1 Open
Recall Number Z-1708-2014
Recall Event ID 68153
Premarket Notification
510(K) Number
K030786 
Product Classification Suture, Surgical, Absorbable, Polydioxanone - Product Code NEW
Product 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
Code Information Lot 130826-08, expiration 2015-07.
Recalling Firm/
Manufacturer
C P Medical Inc.
803 NE 25th Avenue
Portland, Oregon 97232-2304
For Additional Information Contact Barbara Keller Horton
503-232-1555
Manufacturer 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.
FDA Determined
Cause 2
TRAINING: Employee Error
Action CP Medical, Inc., sent a Recall Notice letter dated April 28, 2014 to affected customers. The letter identified the affect product, problem and actions to be taken. The letter instructed customers to immediately discontinue selling or using the recalled product and return all existing stock to CP Medical. They also request their customers to contact downstream customers and request that all their existing stock be returned. CP Medical, Inc. asks all customers to provide them with information as to the quantity of recalled product they are able to return and for all stock they are not able to recover, customers are asked to provide quantity information and location of the product for accountability purposes. The firm requests that all customers contact their customer service representative at 1-800-950-2763 for a Return Goods Authorization (RGA) # and shipping account number. All shipping costs, including those from customers, will be paid for by CP Medical. Replacement product (at no cost) will be provided.
Quantity in Commerce US distribution:4 boxes/ 12 sutures per box (48 total); Outside US: 44 boxes/12 sutures per box. (528 total).
Distribution Worldwide Distribution - US Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NEW and Original Applicant = CP MEDICAL
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