Device recall: (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#…
Class II FDA enforcement event 84661. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Microscopic tears of the sterile pouch may compromise sterility
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Vitreq Bv started this device recall on 17 Dec 2019. The firm address in the FDA record is in Vierpolders. FDA put the recall in Class II. FDA event 84661 has 16 product records. The first FDA enforcement report date is 5 Feb 2020. The record gives the status Terminated, with the termination date 9 Dec 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide
Recalling firm
Vitreq Bv, Vierpolders, N/A, Netherlands.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
16 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0846-2020 | (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0847-2020 | (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0848-2020 | (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0849-2020 | VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0850-2020 | VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0851-2020 | VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0852-2020 | VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0853-2020 | VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0854-2020 | VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0855-2020 | VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0856-2020 | VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0857-2020 | VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0858-2020 | VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0859-2020 | VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0860-2020 | VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645 | N/A | Class II | Terminated | 5 Feb 2020 |
| Z-0861-2020 | VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669 | N/A | Class II | Terminated | 5 Feb 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 16
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0846-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 84661. https://recallregister.com/fda/ii/84661/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide
- What quantity of product is in FDA event 84661?
- The event has 16 product records. The first record gives this quantity:
N/A
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.