Medical device recalls Moderate risk

Teleflex Medical recalls Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

Recall date
March 13, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1404-2015
FDA classification
Class II
Brand / firm
Teleflex Medical
Sold / distributed
US Distribution to the states of : AK, AL, AR, CA, CO, FL, GA, IL, IN, KY, KS, MA, MD, MI, MN, NY, OH, PA, RI, SC, TX, VA WI and WV.

Why it was recalled

Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

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

What was recalled

Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx Only, Teleflex Medical.

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