FDA recall Z-0265-2023

Medical Action Industries, Inc. 306 · Class II · device

Product

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

US Nationwide distribution in the state of Pennsylvania.

Key facts

Status
Terminated
Initiation date
2022-09-15
Report date
2022-11-30
Termination date
2025-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Arden, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0265-2023