Recall Z-2858-2026 ยท PEV Dialysis Administration Kit
Medical Action Industries, Inc. 306
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
| Date | Aug 3, 2026 (initiated May 21, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 th |
| Quantity | 3740 kits (180 cases) |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.