20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Reported: March 23, 2022 Initiated: December 15, 2021 #Z-0804-2022
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.
Details
- Recalling Firm
- CellEra LLC
- Units Affected
- 17850 ea
- Distribution
- US Nationwide distribution.
- Location
- Monroe, OH
Frequently Asked Questions
What product was recalled? ▼
20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box. Recalled by CellEra LLC. Units affected: 17850 ea.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2022. Severity: Low. Recall number: Z-0804-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11