Vitreq Recalls VitreQ 25G VFI Cannulas Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 25G 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 (compromised sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Vitreq Bv is recalling VitreQ 25G VFI Cannulas (REF: CN25.D03, GTIN: 8719214221447) due to a potential sterility issue. The recall covers all lots of the product, which is distributed nationwide.
The recall was initiated because microscopic tears in the sterile pouch may compromise the sterility of the cannulas. This defect could potentially affect the safety of the medical device during use.
Healthcare providers and facilities that have received these cannulas should stop using them and contact Vitreq Bv for further instructions on the recall process.
The recalled product
- Product
- VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447
- 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
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- 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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