Z-1300-2020Class II

Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201

Name: Z-1300-2020 Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
Creator: Covidien LLC
Published: 2019-12-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-12-18 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201 on 2019-12-18. FDA classified it as Class II and gives the reason as "There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots". 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-1300-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-18
Posted: 2020-02-19
Terminated: 2022-08-16
Recalling firm: Medtronic, Inc.
Product: Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On December 18, 2109, Medtronic issued Urgent Medical Device Recall and Return Form notices to customers via courier service. Customers were advised to take the following required actions: 1. Please immediately quarantine and discontinue use of the affected item code and lot listed within the notice. 2. Please return affected product as indicated within the notice. All unused products from the affected item codes and lots must be returned. 3. If you have distributed any of the Polysorb braided or Biosyn monofilament absorbable sutures listed on the recall notice, please promptly forward the information from the letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory.
Quantity in commerce: 139,938 units total
Distribution: US Nationwide distribution.
Product codes and lots: Lot - D7H0404X Expiration Date - 2022-08-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1300-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1274-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1275-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1276-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1277-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1278-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1279-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1280-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1281-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1282-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1283-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1284-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1285-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1286-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1287-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1288-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1289-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1290-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1291-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1292-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1293-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1294-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1295-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1296-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1297-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1298-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1299-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1300-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19

Product code GAM

K000037Class IIMonofilament Biosyn SutureUnited States Surgical, A Division of Tyco Healthc / cleared 2000-03-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)