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Recall Observatory FDA recall evidence

Device product

Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case

Z-2007-2026

March 17, 2026

Class I

Product summary

Firm
Medical Action Industries, Inc. 306
Event
Event 98698
Status
Ongoing
Classification
Class I
Quantity
2030 kits
Official record key
device-enforcement:Z-2007-2026

Official wording

Reason: Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"

Code information: UDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789

Distribution pattern: US distribution to state of: AZ OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"