Recall Z-1394-2024 ยท LRS I.V. Start Kit
Medical Action Industries, Inc. 306
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
| Date | Mar 28, 2024 (initiated Jan 15, 2024) |
| Status | Open, Classified |
| Reason | The kits contain saline flush syringes which were recalled by the supplier. |
| 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 convenienc |
| Quantity | 206,200 kits |
| Distribution | US Nationwide distribution in the states of MN and ND. There as no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.