Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
- Company
- Medical Action Industries Inc
- Recall Initiated
- November 4, 2022
- Posted
- December 21, 2022
- Recall Number
- Z-0751-2023
- Quantity
- 198 cases
- Firm Location
- Arden, NC
Reason for Recall
XXX
Distribution
US Nationwide distribution in the state of VA.
Lot / Code Info
UDI/DI 10809160156681, Lot Numbers: 297223, 297418
Root 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."