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Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

FDA Recall #Z-0731-2016 — Class II — December 21, 2015

Recall #Z-0731-2016 Date: December 21, 2015 Classification: Class II Status: Terminated

Product Description

Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

Reason for Recall

All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.

Recalling Firm

Baxter Corporation Englewood — Englewood, CO

Classification

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

Product Type

Devices

Product Quantity

4,695

Distribution

Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.

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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