FDA recall Z-0847-2020
Vitreq Bv · Class II · device
Product
(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
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2019-12-17
- Report date
- 2020-02-05
- Termination date
- 2020-12-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Vierpolders, N/A, Netherlands
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0847-2020