Z-1394-2024Class II

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

Name: Z-1394-2024 IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile
Creator: Medical Action Industries, Inc. 306
Published: 2024-01-15
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2024-01-15 / Open, Classified / root cause: supplier

FDA source

Medical Action Industries, Inc. 306 began a recall of IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile on 2024-01-15. FDA classified it as Class II and gives the reason as "The kits contain saline flush syringes which were recalled by the supplier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1394-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-15
Posted: 2024-03-28
Recalling firm: Medical Action Industries, Inc. 306
Product: IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Product code: LRS I.V. Start Kit
Reason for recall: The kits contain saline flush syringes which were recalled by the supplier.
Root cause tag: supplier
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters via email on 1/15/2024 explaining the details of the event and the actions to take. The consignee is to immediately discontinue use of all recalled Aquastat Prefilled Saline Flush 3mL & 5mL fill in 12mL Syringes contained in the kits. If the consignee has distributed kits containing these syringes, they are to notify their customers by including a copy of the recall letter. A warning label template was enclosed for the consignee to print which can be affixed on all affected kits in inventory. The warning label should be applied to each affected convenience kit and product case in a prominently visible location to the end user. The location of the warning label should not cover any other critical product information found on the existing product labeling. The Recall Response Form was to be completed and returned as soon as possible.
Quantity in commerce: 206,200 kits
Distribution: US Nationwide distribution in the states of MN and ND. There as no foreign/military/government distribution.
Product codes and lots: Lot numbers 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, and 313961;UDI-DI 10809160020388.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1394-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1394-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-28

Product code LRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)