B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214… recallZ-0265-2023 · Medical Action Industries, Inc. 306 · initiated Sep 15, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medical Action Industries, Inc. 306 or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected]. Any adverse events associated with the use of the affected products should be reported to [email protected]. The FDA requires that we account for all affected products. Therefore, please complete the attached Response Form and return to [email protected] as soon as possible even if you have no current product inventory. If you have any questions, please send an email to [email protected]."
Recall details
- Recall number
- Z-0265-2023
- Status
- Terminated
- Initiated by the company
- Sep 15, 2022
- Posted by the FDA
- Nov 18, 2022
- Recalling firm
- Medical Action Industries, Inc. 306
- Quantity
- 240 cases of 20 units
- Product code
- OFF
- Distribution
- US Nationwide distribution in the state of Pennsylvania.
Product description
B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
Code information (models, lots, serial numbers)
UDI/DI 10809160283875, Batch/Lot number 298442
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BBraun 375214Medical Action Industries Inc. · Central venous catheter tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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