Z-0140-2015Class II

Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled...

Name: Z-0140-2015 Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled...
Creator: C P Medical, Inc.
Published: 2014-09-22
License: https://open.fda.gov/license/

C P Medical Inc. / initiated 2014-09-22 / Terminated / root cause: manufacturing process

FDA source

C P Medical, Inc. began a recall of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner... on 2014-09-22. FDA classified it as Class II and gives the reason as "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...". 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-0140-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-22
Posted: 2014-10-27
Terminated: 2015-02-17
Recalling firm: C P Medical Inc.
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.
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
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.
Root cause tag: manufacturing process
FDA 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 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
Product codes and lots: Product Lot Number (s) Code L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0140-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0140-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-27

Product code NEW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)