Skip to content
Recall Observatory FDA recall evidence

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

October 12, 2022

Class II

Product summary

Firm
Medical Action Industries, Inc. 306
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

    reason.labeling_packaging · v1.0.0

    incorrectly labeled