CellEra LLC: Medical Device Recall in 2022 - (Recall #: Z-0805-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box

Product Classification:

Class III

Date Initiated: December 15, 2021

Date Posted: March 23, 2022

Recall Number: Z-0805-2022

Event ID: 89453

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.

Status: Terminated

Product Quantity: 11770 ea

Code Information:

Lot 212299, 200999 GTIN 10850005565250, 00850005565253, 00850005565246

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated