FDA recall Z-0801-2022

Product

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.

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2021-12-15

Report date

2022-03-23

Termination date

2023-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Monroe, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0801-2022