🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 2, 2022 Covidien Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    GTIN: 20612479214235, 20612479214419, 20612479214495, 20612479213283, 20612479214235, 20612479213269 Lot # (1) D1L0912FY (2) D1G1840FY (3) D2B1262FY (4) D1M2377FY (5) D1M2847FY (6) D2D1386FY (7) D2B0756FY
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Covidien, LP
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1173-2023

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