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U.S. Department of Health and Human Services

Class 2 Device Recall Medical action Industries Dialysis Change Tray Clear Sequence

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 Class 2 Device Recall Medical action Industries Dialysis Change Tray Clear Sequencesee related information
Date Initiated by FirmMay 21, 2026
Date PostedAugust 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2858-2026
Recall Event ID 99338
Product Classification Dialysis administration kit - Product Code PEV
ProductBrand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Code Information Lot Code: Lot No.: 327075 328690 319980 320965 318461 322375 325653 330775 331356 336680 UDI: 20809160242558
FEI Number 1030451
Recalling Firm/
Manufacturer		 Medical Action Industries, Inc. 306
25 Heywood Rd
Arden NC 28704-9302
Manufacturer Reason
for Recall		Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn May 21, 2026 Medical Action Industries issued a "Urgent: Medical Device" Recall notification via Email. Medical Action Industries asked consignees to take the following actions: 1. Identify, Segregate, and Quarantine all impacted kits listed in Table 1. 2. Add warning labels to affected AVID kits to ensure all users are aware of discarding the impacted component prior to use. 3. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. 4. Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 6. Complete the attached Recall Response Form and return by June 5, 2026.
Quantity in Commerce3740 kits (180 cases)
DistributionUS Nationwide distribution in the state of CA.
Total Product Life CycleTPLC 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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