Z-0265-2023 Class II Terminated
FDA device recall Z-0265-2023 was initiated by Medical Action Industries, Inc. 306 on September 15, 2022 and is designated Class II. Reason for recall: The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024. The recall status is terminated (terminated February 19, 2025). Affected quantity: 240 cases of 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2022
- Initiation Date
- September 15, 2022
- Termination Date
- February 19, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240 cases of 20 units
Product Description
B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
Reason for Recall
The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Distribution Pattern
US Nationwide distribution in the state of Pennsylvania.
Code Information
UDI/DI 10809160283875, Batch/Lot number 298442