Recall Z-0140-2015 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
C P Medical, Inc.
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.
| Date | Oct 27, 2014 (initiated Sep 22, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 re |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.