Vitreq Recalls VitreQ 23G Silicone Tipped Cannula Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 23G Silicone Tipped 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, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Vitreq Bv is recalling VitreQ 23G Silicone Tipped Cannulas (GTIN: 8719214221508) due to a potential sterility issue. The recall is being conducted by the U.S. Food and Drug Administration (FDA) under recall number Z-0855-2020.
The recall is necessary because microscopic tears in the sterile pouch may compromise the sterility of the device. This defect could potentially affect the safety of the product for medical use.
The recall covers all lots of the product, which were distributed nationwide. Healthcare providers and facilities that have received this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the units.
The recalled product
- Product
- VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
- 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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See all →- HighVitreq Recalls VitreQ 23G Cannulas Due to Potential Sterility Compromise
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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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