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(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-B...

FDA Recall #Z-0847-2020 — Class II — December 17, 2019

Recall #Z-0847-2020 Date: December 17, 2019 Classification: Class II Status: Terminated

Product Description

(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188

Reason for Recall

Microscopic tears of the sterile pouch may compromise sterility

Recalling Firm

Vitreq Bv — Vierpolders, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

N/A

Distribution

Nationwide

Code Information

All lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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