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VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386

FDA Recall #Z-0850-2020 — Class II — December 17, 2019

Recall #Z-0850-2020 Date: December 17, 2019 Classification: Class II Status: Terminated

Product Description

VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386

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

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