🔍 RecallPedia

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Class I - Dangerous
🏥 Medical Devices Recalled: February 18, 2020 Avid Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Item Codes: ADCO026-17, SINA217. Lot Numbers: 1336261, 1361099, 1363225, 1367696, 1371095, 1374420, 1376394, 1383159. Expiration dates: 02/10/2020-11/18/2022.
  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:
Avid Medical, Inc.
Reason for Recall:
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Product Codes/Lot Numbers:

Item Codes: ADCO026-17, SINA217. Lot Numbers: 1336261, 1361099, 1363225, 1367696, 1371095, 1374420, 1376394, 1383159. Expiration dates: 02/10/2020-11/18/2022.

Distribution:

Distributed in: US, AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX, WI, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1521-2020

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