CLASS I ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

Medical Action Industries Inc. Pack Cath BHH recalled

Medical Action Industries Inc. 306 is recalling Medical Action Industries Inc. Pack Cath BHH, distributed in Arizona. The recall was initiated on 17 Mar 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789
Quantity recalled2030 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2007-2026
FDA event ID
98698
Recalling firm
Medical Action Industries Inc. 306, Arden, NC
Classification
Class I
Status
Ongoing
Recall initiated
17 Mar 2026
FDA classified
6 May 2026
Reported
13 May 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

17 Mar 2026Recall initiated by company
6 May 2026Classified by FDA+50 days
13 May 2026Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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"

Product as listed by the FDA

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

Where it was distributed

US distribution to state of: AZ OUS: None

Arizona

Questions about this recall

Why was it recalled?

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"

Which lots are affected?

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

Where was it sold?

US distribution to state of: AZ OUS: None

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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