Z-1872-2017Class II

PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile...

Name: Z-1872-2017 PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile...
Creator: CP Medical Inc
Published: 2017-02-02
License: https://open.fda.gov/license/

Cp Medical / initiated 2017-02-02 / Open, Classified

FDA source

CP Medical Inc began a recall of PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922... on 2017-02-02. FDA classified it as Class II and gives the reason as "The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1872-2017
Classification: Class II
Status: Open, Classified
Initiated: 2017-02-02
Posted: 2017-04-20
Recalling firm: Cp Medical
Product: PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.
FDA root cause: Unknown/Undetermined by firm
Action: The affected distributors/customers were contacted directly via telephone or by e-mail on February 6-7, 2017. Those end users not contacted by CP Medical directly will be contacted by their distributor
Quantity in commerce: 504 boxes/12 sutures - 6,048 individual sutures
Distribution: AL, AZ, AR, CA, CO, CT, FL, ID, IL, IN, KY, LA, MT, NE, NJ, NM, NY, OK, OR, SC, TX, WA and South Africa
Product codes and lots: Lot Numbers - 150323-04, 150324-04, 150520-10, 150615-01, 150616-08, 150709-01, 151229-64, 160414-69, 160510-59, 160617-52, 160824-50

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1872-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1872-2017	Class II	Ongoing	Voluntary: Firm initiated	2017-04-26	2017-04-20

Product code GAM

K072229Class IIMonoswiftCp Medical / cleared 2007-10-05

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)