Vitreq 20G Needles Recalled for Potential Sterility Compromise
Vitreq Bv is recalling VitreQ 20G Blunt and Brush Needles because microscopic tears in the sterile pouch may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 20G BF Blunt Needles (Ref: BF20.D51, GTIN: 8719214221089) and VitreQ 20G BF Brush Needles (Ref: BF20.D52, GTIN: 8719214221102). The recall covers all lots of these products, which were distributed nationwide.
The recall is being issued because microscopic tears in the sterile pouch may compromise the sterility of the needles. This defect poses a risk of infection if the compromised sterile barrier is used in a clinical setting.
Healthcare providers and facilities that have received these products should stop using them and contact Vitreq Bv for instructions on return or disposal. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102
- Manufacturer
- Vitreq Bv
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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- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
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