FDAHealthMarch 13, 2026
AVID Medical, Inc. — Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
⚠️ 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.
Is this relevant to me?
- Geography
- US, FL, IL, MO, MS, NC, NE, TX
- Source agency
- FDA
- Category
- Health
- Published
- March 13, 2026
US distribution to FL, IL, MO, MS, NC, NE, TX.
What's affected?
- Product
- Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
- Brand
- AVID Medical, Inc.
- Lot code
- ):
Additional details
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).
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 2,932 kits.
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