Z-0265-2023Class II

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

Name: Z-0265-2023 B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number...
Creator: Medical Action Industries, Inc. 306
Published: 2022-09-15
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2022-09-15 / Terminated / root cause: labeling and UDI

FDA source

Medical Action Industries, Inc. 306 began a recall of B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022) on 2022-09-15. FDA classified it as Class II and gives the reason as "The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0265-2023
Classification: Class II
Status: Terminated
Initiated: 2022-09-15
Posted: 2022-11-18
Terminated: 2025-02-19
Recalling firm: Medical Action Industries, Inc. 306
Product: B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
Product code: OFF Central Venous Catheter Tray
Reason for recall: The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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]."
Quantity in commerce: 240 cases of 20 units
Distribution: US Nationwide distribution in the state of Pennsylvania.
Product codes and lots: UDI/DI 10809160283875, Batch/Lot number 298442

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0265-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0265-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-18

Product code OFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)