20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
FDA device recall Z-0801-2022 · posted 2022-03-16 · Terminated
Recall details
- Recalling firm
- CellEra LLC
- 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.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 30,000 ea
- Distribution
- US Nationwide distribution.
- Date initiated
- 2021-12-15
- Date posted
- 2022-03-16
- Date terminated
- 2023-10-16
- Location
- Monroe, OH
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