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U.S. Department of Health and Human Services

Class 2 Device Recall Medical Action INDUSTRIES INC.

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  Class 2 Device Recall Medical Action INDUSTRIES INC. see related information
Date Initiated by Firm November 04, 2022
Date Posted December 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-0751-2023
Recall Event ID 91180
Product Classification Catheter introducer kit - Product Code OFD
Product Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Code Information UDI/DI 10809160156681, Lot Numbers: 297223, 297418
Recalling Firm/
Medical Action Industries, Inc. 306
25 Heywood Rd
Arden NC 28704-9302
Manufacturer Reason
for Recall
FDA Determined
Cause 2
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 in Commerce 198 cases
Distribution US Nationwide distribution in the state of VA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.