FDA-Device2016-02-10Class II

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

Baxter Corporation Englewood
Hazard

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

Sold states
Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
Affected count
4,695
Manufactured in
9540 Maroon Cir Unit 400, N/A, Englewood, CO, United States
Products
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0731-2016

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