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U.S. Department of Health and Human Services

Class 3 Device Recall 20544 Vitale Silver calcium Alginate Dressing Ropes

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 Class 3 Device Recall 20544 Vitale Silver calcium Alginate Dressing Ropessee related information
Date Initiated by FirmDecember 15, 2021
Date PostedMarch 16, 2022
Recall Status1 Terminated 3 on October 16, 2023
Recall NumberZ-0803-2022
Recall Event ID 89453
Product Classification Dressing, wound, drug - Product Code FRO
Product20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Code Information Lot 206999 GTIN 10856276008663, 00856276008666, 00856276008659
Recalling Firm/
Manufacturer		 CellEra LLC
1045 Reed Dr Ste C
Monroe OH 45050-1717
For Additional Information Contact
513-539-1500
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionOn December 15, 2021, the firm notified customers who had received product from CellEra within the past six months. The firm requested these customers hold any merchandise on hand pending receipt of replacement IFU's. The firm communicated with those companies to determine how many new IFU's they require for their inventory and for their customers.
Quantity in Commerce4400 ea
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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