Recall Z-0751-2023
Medical Action Industries, Inc. 306 · initiated November 4, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Codes / lots: UDI/DI 10809160156681, Lot Numbers: 297223, 297418
Reason for recall
XXX
FDA-determined cause: Under Investigation by firm
Action taken
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."
Details
- Recall number
- Z-0751-2023
- Initiated
- November 4, 2022
- Posted by FDA
- December 21, 2022
- Terminated
- March 18, 2026
- Product code
- OFD – Catheter Introducer Kit
- Quantity
- 198 cases
- Distribution
- US Nationwide distribution in the state of VA.
- Recalling firm
- Medical Action Industries, Inc. 306, Arden, NC