FDAFDA · Food and drugs·Recall number Z-0464-2023
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.
Published December 14, 2022 · Recall initiated: October 12, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medical Action Industries, Inc. 306
- Distributor
- Distribution was made to MN. There was no foreign/government/military distribution.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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