Monroe, OH, United States
CellEra LLC recalls
2 recalls recorded since 2018, most recently on 15 December 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 15 December 2021
- Terminated
- 16 October 2023
- Reason
- 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
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0804-2022, Z-0802-2022, Z-0803-2022, Z-0801-2022, Z-0805-2022
- 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
- 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
- 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
- 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
- 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
Terminated Class II Medical devices
- Recall started
- 1 September 2016
- Terminated
- 9 February 2021
- Reason
- Adhesive border was not sticky enough.
- Distribution
- OH, PA, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2085-2019
- VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.