FDA Medical Device Recalls (openFDA)
Medical Action Industries, Inc. 306: Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
- Recall number
- Z-2007-2026
- Recalling firm
- Medical Action Industries, Inc. 306
- Product
- Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
- Status
- Open, Classified
- Initiated
- 2026-03-17
- Posted
- 2026-05-06
- Terminated
- not on file
- 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"
- Root cause
- Unknown/Undetermined by firm
- Action
- On April 22, 2026, Medial Action Industries, Inc. (subsidiary of Owens & Minor) issued a "Urgent: Medical Device Recall Notification Update" via E-Mail to affected consignees. The updated notification provided clarity and and additional information for the recall strategy. Initial notification was issued on March 17, 2026. Medical Action Industries asked consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product. Convenience kits can still be used once properly labeled. 2. Add warning labels to affected Medical Action kits to ensure all users are aware of the actions below and identified in the Medline recall notice. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. 3. If your firm used the labeling template provided with the initial letter, please adhere the revised label over the existing template label. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. 3. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 4. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 5. Complete the attached Recall Response Form and return by April 30, 2026. If you have any questions, contact Reg. Affairs Manager, Kitting, Global Products, by email: GM-OMRA_RECALLS@owens-minor.com or 470-280-4277.
- Quantity
- 2030 kits
- Distribution
- US distribution to state of: AZ OUS: None
- Lot, serial or model codes
- UDI:20809160490294/ Lot numbers: 342509, 346066, 338434, 339423, 337365, 335489, 336189, 336789
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1030451
- Firm city
- Arden
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28