Product Safety Recalls

Product Recall Tracker

CellEra LLC Recall 89453

Description: 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

CellEra LLC Recall 89453 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0804-2022
Event ID89453
Event Description20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity17850 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 212299 GTIN 10856276008700, 00865276008703, 00856276008697
Center Classification Date20220316
Recall Initiation Date20211215
Recalling FirmCellEra LLC
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