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Recall Observatory FDA recall evidence

Device product

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

Z-1975-2026

March 13, 2026

Class I

Product summary

Firm
AVID Medical, Inc.
Event
Event 98686
Status
Ongoing
Classification
Class I
Quantity
2,932 kits
Official record key
device-enforcement:Z-1975-2026

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: 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 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.