Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Summary
The FDA issued a Class I for Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx O by Medical Action Industries, Inc. 306. Reason: Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection betw.
Details
Source
Device Recall
External ID
Z-2007-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Lot/Code Info: UDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789
Quantity Affected: 2030 kits
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"
Distribution
US distribution to state of: AZ OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-17
Company
Arden, NC
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 250 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medical Action Industries, Inc. 306 has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medical Action Industries, Inc. 306) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medical Action Industries, Inc. 306 have FDA actions?
Medical Action Industries, Inc. 306 has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2007-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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