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

FDA device recall Z-1394-2024 · posted 2024-03-28 · Open, Classified

Recall details

Recalling firm

Medical Action Industries, Inc. 306

Reason for recall

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

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LRS

Quantity affected

206,200 kits

Distribution

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

Date initiated

2024-01-15

Date posted

2024-03-28

Location

Arden, NC