Vitreq Recalls VitreQ 23G Cannulas Due to Potential Sterility Compromise
Vitreq Bv is recalling VitreQ 23G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Vitreq Bv is recalling VitreQ 23G VFI Cannulas (REF: CN23.D03, GTIN: 8719214221423). The recall is being conducted because microscopic tears in the sterile pouch may compromise the sterility of the device.
The recall covers all lots of the product and is distributed nationwide. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of these devices.
Healthcare providers and consumers should stop using the affected cannulas and contact Vitreq Bv for further instructions or a replacement.
The recalled product
- Product
- VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423
- Manufacturer
- Vitreq Bv
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Vitreq Bv under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
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- HighVitreq Bv Recalls VitreQ 25G Blunt Needles Due to Sterility Concerns
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- HighVitreq Recalls VitreQ 20G VFI Cannulas Due to Sterility Concerns
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- HighVitreq Bv Recalls VitreQ 23G Pick Needles Due to Sterility Concerns
FDA (Devices) · 2020-02-05
- HighVitreq Recalls VitreQ 25G VFI Cannulas Due to Sterility Concerns
FDA (Devices) · 2020-02-05
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