Recall Z-1394-2024
Medical Action Industries, Inc. 306 · initiated January 15, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Codes / lots: Lot numbers 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, and 313961;UDI-DI 10809160020388.
Reason for recall
The kits contain saline flush syringes which were recalled by the supplier.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1394-2024
- Initiated
- January 15, 2024
- Posted by FDA
- March 28, 2024
- Product code
- LRS – I.V. Start Kit
- Quantity
- 206,200 kits
- Distribution
- US Nationwide distribution in the states of MN and ND. There as no foreign/military/government distribution.
- Recalling firm
- Medical Action Industries, Inc. 306, Arden, NC