B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
- Company
- Medical Action Industries Inc
- Recall Initiated
- September 15, 2022
- Posted
- November 18, 2022
- Terminated
- February 19, 2025
- Recall Number
- Z-0265-2023
- Quantity
- 240 cases of 20 units
- Firm Location
- Arden, NC
Reason for Recall
The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Distribution
US Nationwide distribution in the state of Pennsylvania.
Lot / Code Info
UDI/DI 10809160283875, Batch/Lot number 298442
Root Cause
Under Investigation by firm
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."