Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit

FDA device recall Z-0751-2023 · posted 2022-12-21 · Terminated

Recall details

Recalling firm

Medical Action Industries, Inc. 306

Reason for recall

XXX

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."

Root cause

Under Investigation by firm

Status

Terminated

Product code

OFD

Quantity affected

198 cases

Distribution

US Nationwide distribution in the state of VA.

Date initiated

2022-11-04

Date posted

2022-12-21

Date terminated

2026-03-18

Location

Arden, NC