Vitreq Recalls VitreQ 27G Cannulas Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 27G 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, fitting the High severity criteria.
Plain-English summary
Vitreq Bv is recalling VitreQ 27G VFI Cannulas (REF: CN27.D03, GTIN: 8719214221461). The recall covers all lots of the product, which was distributed nationwide.
The recall was initiated because microscopic tears of the sterile pouch may compromise sterility. This defect could potentially affect the safety of the medical device.
Healthcare providers and facilities that have received this product should stop using it and contact Vitreq Bv for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461
- 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
Same manufacturer · Vitreq Bv
See all →- HighVitreq Recalls VitreQ 23G Cannulas Due to Potential Sterility Compromise
FDA (Devices) · 2020-02-05
- HighVitreq 25G Blunt and Brush Needles Recalled for Sterility Risk
FDA (Devices) · 2020-02-05
- HighVitreq Bv Recalls VitreQ 25G Blunt Needles Due to Sterility Concerns
FDA (Devices) · 2020-02-05
- HighVitreq Recalls VitreQ 20G VFI Cannulas Due to Sterility Concerns
FDA (Devices) · 2020-02-05
- HighVitreq Bv Recalls VitreQ 23G Pick Needles Due to Sterility Concerns
FDA (Devices) · 2020-02-05
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