FDA Medical Device Recalls (openFDA)
Medical Action Industries, Inc. 306: Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
- Recall number
- Z-0751-2023
- Recalling firm
- Medical Action Industries, Inc. 306
- Product
- Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
- Status
- Terminated
- Initiated
- 2022-11-04
- Posted
- 2022-12-21
- Terminated
- 2026-03-18
- Reason
- XXX
- Root cause
- Under Investigation by firm
- Action
- The recalling firm issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its sole consignee by email on 11/04/2022. The notice explained the issue and request the following actions be taken: "Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. A labeling template for each LOT is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If you prefer to have labels printed for your facility, please send quantity and end-user information to quality@owens-minor.com." "If you have any questions, please send an email to Quality@owens-minor.com."
- Quantity
- 198 cases
- Distribution
- US Nationwide distribution in the state of VA.
- Lot, serial or model codes
- UDI/DI 10809160156681, Lot Numbers: 297223, 297418
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFD
- 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