Z-0847-2020 Class II Terminated
FDA device recall Z-0847-2020 was initiated by Vitreq Bv on December 17, 2019 and is designated Class II. Reason for recall: Microscopic tears of the sterile pouch may compromise sterility The recall status is terminated (terminated December 9, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- December 17, 2019
- Termination Date
- December 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188
Reason for Recall
Microscopic tears of the sterile pouch may compromise sterility
Distribution Pattern
Nationwide
Code Information
All lots