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U.S. Department of Health and Human Services

Class 2 Device Recall VITALE Silicon Foam Dressings 4"x4"

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 Class 2 Device Recall VITALE Silicon Foam Dressings 4"x4"see related information
Date Initiated by FirmSeptember 01, 2016
Create DateJuly 25, 2019
Recall Status1 Terminated 3 on February 09, 2021
Recall NumberZ-2085-2019
Recall Event ID 83281
Product Classification Dressing, wound, hydrogel without drug and/or biologic - Product Code NAE
ProductVITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
Code Information Lot # 161616 Cat. No. 20144 HIBCC bar code was M6692014409
FEI Number 3007594734
Recalling Firm/
Manufacturer		 CellEra LLC
1045 Reed Dr Ste C
Monroe OH 45050-1717
For Additional Information ContactDick Moon
513-539-1500
Manufacturer Reason
for Recall		Adhesive border was not sticky enough.
FDA Determined
Cause 2		Other
Actionfirm contacted the facilities (via phone) that were shipped the merchandise and offered to take the product back.
Quantity in Commerce2110 units
DistributionOH, PA, VA
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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