FDA-Device2022-12-14Class II
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.
Medical Action Industries, Inc. 306
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.
Sold states
Distribution was made to MN. There was no foreign/government/military distribution.
Affected count
24 cases (480 kits)
Manufactured in
25 Heywood Rd, N/A, Arden, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2023Don't want to check this manually?
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