Z-1708-2014Class II

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

Name: Z-1708-2014 Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number...
Creator: C P Medical Inc.
Published: 2014-04-23
License: https://open.fda.gov/license/

C P Medical Inc. / initiated 2014-04-23 / 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 PGCL; part number L936. Product is labeled sterile. The product is... on 2014-04-23. FDA classified it as Class II and gives the reason as "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". 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-1708-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-23
Posted: 2014-06-03
Terminated: 2014-09-12
Recalling firm: C P Medical Inc.
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
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: Lot 130826-08, expiration 2015-07.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1708-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1708-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-03

Product code NEW

K030786Class IIMono-SwiftCp Medical / cleared 2003-05-06

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)