B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 1

FDA device recall Z-0265-2023 · posted 2022-11-18 · Terminated

Recall details

Recalling firm

Medical Action Industries, Inc. 306

Reason for recall

The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.

Action taken

Owens & Minor/Medical Action INDUSTRIES, INC. issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its sole consignee on 09/23/2022 by email. The notices explained the issue and requested they take the following actions: "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 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. Any adverse events associated with the use of the affected products should be reported to Quality@owens-minor.com. The FDA requires that we account for all affected products. Therefore, please complete the attached Response Form and return to Quality@owens-minor.com as soon as possible even if you have no current product inventory. If you have any questions, please send an email to marlene.jones@owens-minor.com."

Root cause

Under Investigation by firm

Status

Terminated

Product code

OFF

Quantity affected

240 cases of 20 units

Distribution

US Nationwide distribution in the state of Pennsylvania.

Date initiated

2022-09-15

Date posted

2022-11-18

Date terminated

2025-02-19

Location

Arden, NC