Covidien, LP: 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)

Recall number

Z-1388-2023

Recalling firm

Covidien, LP

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)

Status

Open, Classified

Initiated

2023-03-01

Posted

2023-04-12

Terminated

not on file

Reason

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

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 rs.gmbfcamitg@medtronic.com. " Product purchased directly from Medtronic please contact rs.covidienfeedbackcustomerservice@medtronic.com 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 rs.covidienfeedbackcustomerservice@medtronic.com 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

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.

Lot, serial or model codes

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

510(k) numbers

["K142656"]

PMA numbers

not on file

Product code

GAL

Firm FEI

1219930

Firm city

North Haven

Firm state

CT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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