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U.S. Department of Health and Human Services

Class 2 Device Recall Medical Action Industries

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  Class 2 Device Recall Medical Action Industries see related information
Date Initiated by Firm January 15, 2024
Date Posted March 28, 2024
Recall Status1 Open3, Classified
Recall Number Z-1394-2024
Recall Event ID 94181
Product Classification I.V. start kit - Product Code LRS
Product IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Code Information Lot numbers 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, and 313961;UDI-DI 10809160020388.
Recalling Firm/
Manufacturer		 Medical Action Industries, Inc. 306
25 Heywood Rd
Arden NC 28704-9302
Manufacturer Reason
for Recall		 The kits contain saline flush syringes which were recalled by the supplier.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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