Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791

FDA device recall Z-2858-2026 · posted 2026-08-03 · Open, Classified

Recall details

Recalling firm

Medical Action Industries, Inc. 306

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

PEV

Quantity affected

3740 kits (180 cases)

Distribution

US Nationwide distribution in the state of CA.

Date initiated

2026-05-21

Date posted

2026-08-03

Location

Arden, NC