Moderate riskFDA DeviceClass II

Medical Action dialysis change tray recalled for possible seal defect

Medical Action Industries is recalling Dialysis Change Tray Clear Sequence kits (model 78791) that contain a needle-free access device with an improper seal. The seal may dome or tear. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Medical Action Industries recalls

What to do

  1. Set aside any kits from the lots listed in the notice.
  2. Check lot numbers 327075, 328690, 319980, 320965, 318461, 322375, 325653, 330775, 331356, 336680 and UDI 20809160242558 on the package.
  3. Contact Medical Action Industries for instructions. The notice does not state a remedy such as a replacement or refund.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
3740 kits (180 cases)
Illnesses reported
None reported
Manufactured in
25 Heywood Rd, Arden, NC, United States
Classification
Class II
Recall number
Z-2858-2026

In the FDA's words

Description
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791 Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal. Lot Code: Lot No.: 327075 328690 319980 320965 318461 322375 325653 330775 331356 336680 UDI: 20809160242558 Distribution: US Nationwide distribution in the state of CA. Affected quantity: 3740 kits (180 cases)
Hazard
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.

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