Medical device recalls Moderate risk

Cardinal Health 200, LLC recalls Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1…

Recall date
June 11, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2489-2018
FDA classification
Class II
Brand / firm
Cardinal Health 200, LLC
Sold / distributed
Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherla…

Why it was recalled

The suction valve may not close properly which could cause continuous suction.

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

What was recalled

Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.

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