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Recall Observatory FDA recall evidence

Device product

IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.

Z-1394-2024

January 15, 2024

Class II

Product summary

Firm
Medical Action Industries, Inc. 306
Event
Event 94181
Status
Ongoing
Classification
Class II
Quantity
206,200 kits
Official record key
device-enforcement:Z-1394-2024

Official wording

Reason: The kits contain saline flush syringes which were recalled by the supplier.

Code information: Lot numbers 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, and 313961;UDI-DI 10809160020388.

Distribution pattern: US Nationwide distribution in the states of MN and ND. There as no foreign/military/government distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The kits contain saline flush syringes which were recalled by the supplier.