Medical Action Industries, Inc. Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Brand
Medical Action Industries, Inc.
Lot Codes / Batch Numbers
UDI/DI 10809160156681, Lot Numbers: 297223, 297418
Products Sold
UDI/DI 10809160156681, Lot Numbers: 297223, 297418
Medical Action Industries, Inc. is recalling Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit due to XXX. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
XXX
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026