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Recall Observatory FDA recall evidence

Device product

Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.

Z-1978-2026

March 13, 2026

Class I

Product summary

Firm
AVID Medical, Inc.
Event
Event 98686
Status
Ongoing
Classification
Class I
Quantity
2,392 kits
Official record key
device-enforcement:Z-1978-2026

Official wording

Reason: 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.

Code information: 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).

Distribution pattern: US distribution to FL, IL, MO, MS, NC, NE, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.