Z-2858-2026Class II

Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number...

Name: Z-2858-2026 Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number...
Creator: Medical Action Industries, Inc. 306
Published: 2026-05-21
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2026-05-21 / Open, Classified / root cause: manufacturing process

FDA source

Medical Action Industries, Inc. 306 began a recall of Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791 on 2026-05-21. FDA classified it as Class II and gives the reason as "Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2858-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-21
Posted: 2026-08-03
Recalling firm: Medical Action Industries, Inc. 306
Product: Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Product code: PEV Dialysis Administration Kit
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 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 commerce: 3740 kits (180 cases)
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: Lot Code: Lot No.: 327075 328690 319980 320965 318461 322375 325653 330775 331356 336680 UDI: 20809160242558

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2858-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2858-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-03

Product code PEV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)