Home / Recalls / CellEra LLC / Z-0804-2022

Z-0804-2022 Class III Terminated

Recalled by CellEra LLC — Monroe, OH

Recall Details

Product Type
Devices
Report Date
March 23, 2022
Initiation Date
December 15, 2021
Termination Date
October 16, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17850 ea

Product Description

20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

Reason for Recall

Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.

Distribution Pattern

US Nationwide distribution.

Code Information

Lot 212299 GTIN 10856276008700, 00865276008703, 00856276008697

Other recalls by CellEra LLC

  • Z-0805-2022 Class III — 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box (December 15, 2021)
  • Z-0801-2022 Class III — 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box (December 15, 2021)
  • Z-0803-2022 Class III — 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box (December 15, 2021)
  • Z-0802-2022 Class III — 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box (December 15, 2021)
  • Z-2085-2019 Class II — VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 (September 1, 2016)