Z-0464-2023 Class II Terminated
FDA device recall Z-0464-2023 was initiated by Medical Action Industries, Inc. 306 on October 12, 2022 and is designated Class II. 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. The recall status is terminated (terminated March 25, 2025). Affected quantity: 24 cases (480 kits).
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2022
- Initiation Date
- October 12, 2022
- Termination Date
- March 25, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 cases (480 kits)
Product Description
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 Pattern
Distribution was made to MN. There was no foreign/government/military distribution.
Code Information
Port Access Kit case label - Lot 294281, exp. 9/28/2023, UDI #1080916018095. IV Start Kit label - Lot 294589, exp. 12/20/2024, UDI #20809160195991.