Z-2601-2018Class II

Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955

Name: Z-2601-2018 Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Creator: Covidien LLC
Published: 2018-06-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-06-15 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955 on 2018-06-15. FDA classified it as Class II and gives the reason as "Potential proplylene glycol contamination". 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-2601-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-15
Posted: 2018-08-03
Terminated: 2019-05-08
Recalling firm: Medtronic, Inc.
Product: Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Potential proplylene glycol contamination
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: All U.S. consignees were notified via Federal Express or certified mail on June 15, 2018, and the letter informs customers of the potential that the suture was contaminated with propylene glycol during the manufacturing process and the actions they should take. Customers are advised to discontinue use of the product and return all inventory of the affected lot to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department.
Quantity in commerce: 972 units
Distribution: CA, NY & TX
Product codes and lots: UDI - 10884521043718 /20884521043715 Lot Number - A8C0783X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2601-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2601-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-08-02

Product code GAM

K981935Class IIPolysorb SutureUnited States Surgical, A Division of Tyco Healthc / cleared 1998-06-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)