Device product
(1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102
Z-0848-2020
Product summary
- Firm
- Vitreq Bv
- Event
- Event 84661
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0848-2020
Official wording
Reason: Microscopic tears of the sterile pouch may compromise sterility
Code information: All lots
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Microscopic tears of the sterile pouch may compromise sterility