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U.S. Department of Health and Human Services

Class 2 Device Recall Polyglycolic Acid (PGA) Absorbable Suture

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 Class 2 Device Recall Polyglycolic Acid (PGA) Absorbable Suturesee related information
Date Initiated by FirmJanuary 02, 2009
Date PostedNovember 19, 2011
Recall Status1 Terminated 3 on December 13, 2011
Recall NumberZ-0260-2012
Recall Event ID 60173
510(K)NumberK002190 
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductProduct is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. The product is a Violet, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 Metric), NFS-2 Needle (Product code 398A-Polyglycolic Acid) or size 2/0 (3.0 Metric) NFS-1 Needle. (Product code 453A-Polyglycolic Acid). Product is labeled in part: "***NFS-1***CUTTING***Coated POLYGLYCOLIC ACID Violet (PGA) Braided Absorbable Suture STERILE***Manufacturer CP Medical***". Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. The suture is not recommended for adult cardiac tissue, microsurgery or neural tissue. The absorbable sutures are useful where extended wound support is desirable.
Code Information 398A and 453A
Recalling Firm/
Manufacturer		 C P Medical Inc.
803 NE 25th Avenue
Portland OR 97232-2304
For Additional Information ContactBarbara Keller Horton
503-232-1555
Manufacturer Reason
for Recall		The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCP Medical, Inc. sent a "RECALL NOTICE" letter dated January 5, 2009 to all affected customers.The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to identify affected product and to return the product to the firm. Customers should call 1-503-232-1555 for a return goods authorization number and shipping account number. Contact your customer service representative at 1-800-950-2763 for questions concerning this recall.
Quantity in Commerce13632 sutures
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GAM
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