Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall 20545 Vitale Silver calcium Alginate Dressing Ropes

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall 20545 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-0804-2022
Recall Event ID 89453
Product Classification Dressing, wound, drug - Product Code FRO
Product20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Code Information Lot 212299 GTIN 10856276008700, 00865276008703, 00856276008697
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 Commerce17850 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.
-
-