Z-0801-2022 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2022
- Initiation Date
- December 15, 2021
- Termination Date
- October 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,000 ea
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot 200999 GTIN 10856276008649, 00856276008642, 00856276008635