AVID Medical, Inc.: Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
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 SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
- 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: SAMM066-15. UDI-DI (Kit Lot Numbers): 10809160388495 (1561685, 1575926, 1583048, 1584017, 1589652, 1595715, 1599634, 1605749, 1611810, 1621476, 1637222, 1637224, 1637225, 1643118, 1645143, 1645637, 1663929, 1663930, 1663931, 1663932).
- Product quantity
- 2,392 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Toano
- State
- VA
- Country
- United States
- Event id
- 98686
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