Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model Number: SELF131-05. UDI-DI (Kit Lot Numbers): 10809160408650 (1611688, 1611689, 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656582, 1656581, 1659713, 1670884, 1670885, 1671950).
  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:
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

Product Codes/Lot Numbers:

Model Number: SELF131-05. UDI-DI (Kit Lot Numbers): 10809160408650 (1611688, 1611689, 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656582, 1656581, 1659713, 1670884, 1670885, 1671950).

Distribution:

Distributed in: US, FL, IL, MO, MS, NC, NE, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1975-2026

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