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U.S. Department of Health and Human Services

Class 2 Device Recall Monoswift

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  Class 2 Device Recall Monoswift see related information
Date Initiated by Firm September 22, 2014
Date Posted October 27, 2014
Recall Status1 Terminated 3 on February 17, 2015
Recall Number Z-0140-2015
Recall Event ID 69373
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
Product Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. 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.
Code Information Product Lot Number (s) Code  L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06. 
Recalling Firm/
Manufacturer		 C P Medical, Inc.
803 NE 25th Ave
Portland OR 97232-2304
For Additional Information Contact Customer Service
503-232-1555
Manufacturer Reason
for Recall		 CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product's shelf life.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action CP Medical Inc.notified their customers between September 23 through October 3, 2014, of the recall via telephone or e-mail and followed up with a certified letter. Customers were advised to discontinue sale and/or use of the recalled product and return all existing stock to CP Medical. CP Medical also requested their customers to notify their downstream customers of the recall and request they return any unused recalled product, as well as provide information to them regarding distribution of the product. Customers are being asked to fill out and return a questionnaire regarding the recalled product and contact CP Medical Customer Service Representative at 1-800-950-2763 for return authorization and shipping account number. All shipping costs including those from downstream customers will be paid for by CP Medical. Replacement product or credit will be provided.
Quantity in Commerce 74 boxes /12 sutures per box; plus an additional 13 sutures
Distribution US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA
Total Product Life Cycle TPLC 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.
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