AVID Medical, Inc.: Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- AVID Medical, Inc.
- Product
- Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- US distribution to FL, IL, MO, MS, NC, NE, TX.
- Recall initiated
- 2026-03-13
- Code info
- 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).
- Product quantity
- 2,932 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Toano
- State
- VA
- Country
- United States
- Event id
- 98686
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