FDA-Device2022-03-23Class III
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
CellEra LLC
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
30,000 ea
Manufactured in
1045 Reed Dr Ste C, N/A, Monroe, OH, United States
Products
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0801-2022Don't want to check this manually?
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