CLASS II Device recall · Reported 5 Feb 2020 · FDA Enforcement Report
VitreQ BF Blunt Needles-.D51 GITN recalled by Vitreq Bv
Vitreq Bv is recalling VitreQ BF Blunt Needles-.D51 GITN: 8719214221164 VitreQ BF Brush Needles-.D52, distributed nationwide in the US. The recall was initiated on 17 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0847-2020
- FDA event ID
- 84661
- Recalling firm
- Vitreq Bv, Vierpolders, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2019
- FDA classified
- 24 Jan 2020
- Reported
- 5 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 17 Dec 2019 | Recall initiated by company | |
| 24 Jan 2020 | Classified by FDA | +38 days |
| 5 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microscopic tears of the sterile pouch may compromise sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188
Where it was distributed
Nationwide
Questions about this recall
Is VitreQ BF Blunt Needles-.D51 GITN: 8719214221164 VitreQ BF Brush Needles-.D52 recalled?
Yes. Vitreq Bv recalled VitreQ BF Blunt Needles-.D51 GITN: 8719214221164 VitreQ BF Brush Needles-.D52 on 17 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-0847-2020.
Why was it recalled?
Microscopic tears of the sterile pouch may compromise sterility
Which lots are affected?
All lots
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vitreq Bv
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Blunt Needles with luer-lock connector recalled by Vitreq Bv | Vitreq Bv | Sterility | Nationwide |
| Device | CLASS II | VitreQ BF Blunt Needles recalled by Vitreq Bv | Vitreq Bv | Sterility | Nationwide |
| Device | CLASS II | VFI Cannula recalled by Vitreq Bv | Vitreq Bv | Sterility | Nationwide |
| Device | CLASS II | Blunt Needles with luer-lock connector recalled by Vitreq Bv | Vitreq Bv | Sterility | Nationwide |
| Device | CLASS II | Silicone Tipped Cannula-CN23.D01 recalled by Vitreq Bv | Vitreq Bv | Sterility | Nationwide |
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