Z-1388-2023Class II

Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36...

Name: Z-1388-2023 Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36...
Creator: Covidien, LP
Published: 2023-03-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-03-01 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LP began a recall of Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC... on 2023-03-01. FDA classified it as Class II and gives the reason as "Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1388-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-01
Posted: 2023-04-12
Recalling firm: Medtronic, Inc.
Product: Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45CM P12 X36 (SG-5637), CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G), CHROMIC GUT 5-0 75CM CV23 (UG-202), CHROMIC GUT 4-0 75CM CV23 X36 (UG-203)
Product code: GAL Suture, Absorbable, Natural
Reason for recall: Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An "URGENT PRODUCT RECALL" letter dated 3/1/23 was sent to customers. Actions to be Taken: " Immediately identify and quarantine all unused affected product (Refer to Attachment A for identifying affected product). " Please complete and return the enclosed Customer Confirmation Form, even if you have no product to return and email to [email protected]. " Product purchased directly from Medtronic please contact [email protected] for Return Goods Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Credit for the returned affected product will be issued based on the RGA number. " Return all unused affected product(s) in your inventory to: Medtronic, Attn: Field Returns Dept. 195 McDermott Road, North Haven, CT 06473 USA " If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. " Forward this notification to any entities within your organization or to any other organization where the potentially affected product has been transferred or further distributed. Local contact details: Adverse reactions or quality problems experienced with this product should be reported to FDA and Medtronic: " Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or Call FDA (800) FDA-1088 " Contact Medtronic Customer Service Support at [email protected] or call 800-962-9888, option 2. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Representative Customer Service at 800-962-9888, option 2.
Quantity in commerce: 36204 units
Distribution: Worldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA, NC, NY, OH, WA; and countries of: Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.
Product codes and lots: GTIN: 20884521054001, 20884521054056, 20884521054889, 20884521054896, 20884521054896, 20884521054902, 20884521054902, 10884521054905, 20884521054940, 20884521055688, 20884521055770, 20884521056135, 10884521056145, 20884521056142, 20884521056142, 20884521056142; Lot: D2H1593ZY D2H1022ZY D2F1106ZY D2H1607ZY D2H1609ZY D2H0819ZY D2H2053ZY D2H2053ZY D2H2055ZY D2H1435FZY D2H0829FZY D2H0830FZY D2H0381ZY D2H1523ZY D2H1584ZY D2H1584ZY D2H1587ZY D2H1589ZY

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1388-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1387-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1388-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1389-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1390-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12

Product code GAL

K142656Class IISurgical Gut SutureCovidien / cleared 2015-01-29

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)