Medical device recalls Moderate risk

Cadence Science, Inc. recalls Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (G…

Recall date
May 10, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0365-2020
FDA classification
Class II
Brand / firm
Cadence Science, Inc.
Sold / distributed
US Nationwide distribution in the states of AL, AR, CA, FL, GA, IA, ID, IL, MO, NH, NJ, NY, OH, PA, SC, TX, VA, and WI.

Why it was recalled

The glass syringe used with Pressure Control Syringes may potentially break during use.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use

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