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CellEra LLC Recall 89453

Description: 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

CellEra LLC Recall 89453 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0801-2022
Event ID89453
Event Description20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity30,000 ea
Recall ReasonFirm 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.
Device Classification20220323
Device Code InfoLot 200999 GTIN 10856276008649, 00856276008642, 00856276008635
Center Classification Date20220316
Recall Initiation Date20211215
Recalling FirmCellEra LLC
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