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20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

FDA Recall #Z-0801-2022 — Class III — December 15, 2021

Recall #Z-0801-2022 Date: December 15, 2021 Classification: Class III Status: Terminated

Product Description

20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

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.

Recalling Firm

CellEra LLC — Monroe, OH

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

30,000 ea

Distribution

US Nationwide distribution.

Code Information

Lot 200999 GTIN 10856276008649, 00856276008642, 00856276008635

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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