Recall Z-0847-2020— Vitreq Bv
Class II · Terminated
Class II FDA medical device recall by Vitreq Bv, initiated 2019-12-17, terminated 2020-12-09. FDA's recall record names no specific 510(k) clearance for this event. Product: (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188. Reason: Microscopic tears of the sterile pouch may compromise sterility.
- Recalling firm
- Vitreq Bv
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-17
- Terminated
- 2020-12-09
- Firm location
- Vierpolders, N/A, Netherlands
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.