The Recall Desk
HighFDA (Devices)·Z-0854-2020·Announced 2020-02-05

Vitreq Recalls VitreQ 20G VFI Cannulas Due to Sterility Concerns

Vitreq Bv is recalling VitreQ 20G 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 leading to potential infection) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Vitreq Bv is recalling VitreQ 20G VFI Cannulas (REF: CN20.D03, GTIN: 8719214221485). The recall covers all lots of the product, which was distributed nationwide.

The recall was initiated because microscopic tears in the sterile pouch may compromise the sterility of the cannulas. This defect poses a risk of infection if the product is used in a clinical setting.

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 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485
Manufacturer
Vitreq Bv
Category
Medical Device — Surgical Instruments
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

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Same hazard · infection

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