Summary
The FDA issued a Class III for 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box by CellEra LLC. Reason: Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affecte.
Details
Source
Device Recall
External ID
Z-0802-2022
Action Date
2022-03-23
Status
Terminated
Category
device
Product Description
20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
Lot/Code Info: Lot 229999 GTIN 10856276008762, 00856276008765, 00856276008758
Quantity Affected: 9200 ea
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
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-15
Company
Monroe, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CellEra LLC has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CellEra LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CellEra LLC have FDA actions?
CellEra LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0802-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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