20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
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.
What You Should Do
Remedy
On 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.
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Products
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
- Brand
- CellEra LLC
- UPC
- Lot 200999 GTIN 10856276008649, 00856276008642, 00856276008635
Units Affected
30,000 ea