Z-2858-2026 Class II Ongoing
FDA device recall Z-2858-2026 was initiated by Medical Action Industries, Inc. 306 on May 21, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3740 kits (180 cases).
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- May 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3740 kits (180 cases)
Product Description
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
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.
Distribution Pattern
US Nationwide distribution in the state of CA.
Code Information
Lot Code: Lot No.: 327075 328690 319980 320965 318461 322375 325653 330775 331356 336680 UDI: 20809160242558