Date Initiated by Firm | April 23, 2014 |
Date Posted | June 03, 2014 |
Recall Status1 |
Terminated 3 on September 12, 2014 |
Recall Number | Z-1708-2014 |
Recall Event ID |
68153 |
510(K)Number | K030786 |
Product Classification |
Suture, surgical, absorbable, polydioxanone - Product Code NEW
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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 OR 97232-2304
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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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = NEW
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