FDA recall Z-0464-2023

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

Product

Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.

Reason for recall

The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.

Distribution

Distribution was made to MN. There was no foreign/government/military distribution.

Key facts

Status: Terminated
Initiation date: 2022-10-12
Report date: 2022-12-14
Termination date: 2025-03-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Arden, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2023