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Monofilament Nylon Suture (McKesson Branded) and Coated… recallZ-1173-2023 · Covidien, LP · initiated Dec 2, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-1173-2023
Status
Open, Classified
Initiated by the company
Dec 2, 2022
Posted by the FDA
Feb 25, 2023
Recalling firm
Covidien, LP
Quantity
12732 units
Product code
GAR
FDA submissions
K900531
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 description

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

Code information (models, lots, serial numbers)

GTIN: 20612479214235, 20612479214419, 20612479214495, 20612479213283, 20612479214235, 20612479213269 Lot # (1) D1L0912FY (2) D1G1840FY (3) D2B1262FY (4) D1M2377FY (5) D1M2847FY (6) D2D1386FY (7) D2B0756FY

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

95 devices cleared under K900531 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91324).

Sources and updates

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