FDA Recall Open, Classified

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

Recall: Z-1394-2024 · Initiated January 15, 2024

Recall

Recall Number
Z-1394-2024
Event Number
94181
Firm
Medical Action Industries, Inc.
FEI Number
1030451
Product Code
LRS
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
January 15, 2024
Posted
March 28, 2024
Address
306 25 Heywood Rd, Arden, NC, 28704-9302

Description

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

Reason

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

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.

Distribution

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

Quantity

206,200 kits