Vitreq Bv Recalls VitreQ 23G Blunt Needles Due to Sterility Risk
Vitreq Bv is recalling VitreQ 23G Blunt 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential sterility compromise without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Vitreq Bv is recalling VitreQ 23G Blunt Needles with luer-lock connector (REF: CN23.D05, GTIN: 8719214221621). The recall is being conducted because microscopic tears of the sterile pouch may compromise sterility.
The recall applies to all lots of the product. The distribution pattern is listed as nationwide. The agency classification for this recall is Class II.
Consumers and healthcare providers should stop using the affected needles and contact the recalling firm for further instructions.
The recalled product
- Product
- VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621
- 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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