Smiths Medical ASD, Inc. recalls CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.

Recall date

February 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1286-2015

FDA classification

Class II

Brand / firm

Smiths Medical ASD, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) Distribution to the states of : AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL IN, IA, MD, MA, MN, MS, MO, NE, NV, NH ,NJ, NM, NY, NC, OH, OR, PA, SD, TN, TX, UT, VA and WA., and to the countries of : Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland,…

Why it was recalled

Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.

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

What was recalled

CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.