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Open, Classified

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

FDA Recall Z-2858-2026 · Posted 2026-08-03

Recall StatusOpen, Classified
Product CodePEV
Date Initiated2026-05-21
Product Quantity3740 kits (180 cases)

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the state of CA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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