Z-1173-2023Class II

Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0...

Name: Z-1173-2023 Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0...
Creator: Covidien, LP
Published: 2022-12-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-12-02 / Open, Classified / root cause: packaging

FDA source

Covidien, LP began a recall of Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3)... on 2022-12-02. FDA classified it as Class II and gives the reason as "Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1173-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-02
Posted: 2023-02-25
Recalling firm: Medtronic, Inc.
Product: Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11 (6)S913BX 5-0 NYLON 10 DS12 (7)S931BX 4-0 NYLON 10 DS12
Product code: GAR Suture, Nonabsorbable, Synthetic, Polyamide
Reason for recall: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" letter to US consignees on 01-Dec-2022 via UPS 2-day delivery. OUS countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and actions to take: Actions: " Identify and quarantine all unused and non-expired affected non-absorbable sutures. " Please note the affected product may be located within Custom Suture Packs. Please reference Custom Suture Packs to identify affected product. " Please complete the enclosed Customer Confirmation Form (even if your account no longer has affected product on hand) and email to [email protected].> " Return all unused and non-expired affected product in your inventory to Medtronic as indicated in the Shipping and Return Instructions below. " Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed. Shipping and Return Instructions: " Product purchased directly from Medtronic please contact [email protected] for Return Good Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Credit or Replacement for the returned affected product will be issued based on the RGA number. " Return all unused and non-expired 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. If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888.
Quantity in commerce: 12732 units
Distribution: US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe
Product codes and lots: GTIN: 20612479214235, 20612479214419, 20612479214495, 20612479213283, 20612479214235, 20612479213269 Lot # (1) D1L0912FY (2) D1G1840FY (3) D2B1262FY (4) D1M2377FY (5) D1M2847FY (6) D2D1386FY (7) D2B0756FY

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1173-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1172-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25
Z-1173-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25
Z-1174-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25
Z-1175-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25
Z-1176-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25
Z-1177-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25
Z-1178-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25
Z-1179-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25
Z-1180-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25
Z-1181-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25
Z-1182-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-25

Product code GAR

K900531Class IINonabsorbable Nylon Surgical Suture*United States Surgical, A Division of Tyco Healthc / cleared 1990-07-05

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)