Z-0259-2012

Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an...

Name: Z-0259-2012 Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an...
Creator: C P Medical Inc.
Published: 2009-01-02
License: https://open.fda.gov/license/

C P Medical Inc. / initiated 2009-01-02 / Terminated / root cause: manufacturing process

FDA source

C P Medical Inc. began a recall of Product 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... on 2009-01-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0259-2012
Status: Terminated
Initiated: 2009-01-02
Posted: 2011-11-19
Terminated: 2011-12-13
Recalling firm: C P Medical Inc.
Product: Product 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 4/0 (1.5 Metric), NFS-2 Needle (Product code M397-Polydioxanone) or size 3/0 (2.0 Metric) (Product code M398 {Butler code 029254}). Product is labeled in part: "***POLYDIOANONE Violet (PDO) Monofilament Absorbable Suture***". 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.
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: CP 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 commerce: 13632 sutures
Distribution: Nationwide Distribution
Product codes and lots: M397, M398 (Butler code 029254)

Product code NEW

K013274Class IIMono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,sterileCp Medical / cleared 2001-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)