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.
Z-0464-2023
Product summary
- Event
- Event 91065
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 cases (480 kits)
- Official record key
device-enforcement:Z-0464-2023
Official wording
Reason: 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.
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.
Distribution pattern: Distribution was made to MN. There was no foreign/government/military distribution.
Derived failure modes
-
Labeling or packaging
incorrectly labeled