CADD ADMINISTRATION SET

Model: CADD, Affected: Multiple Lots 21-7321-01

46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001.

General Hospital and Personal Use Devices

2

No

US:AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WV, WY. OUS: Canada

CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.

Medical Device Safety Alert: Smiths Medical CADD Administration Sets with Flow Stop Free

Disposable products

Devices with an expiration date on or before March 2021

General Hospital and Personal Use Devices

2

No

US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE. OUS: UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, MAURITIUS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PORTUGAL, SAUDI ARABIA, SWEDEN, SINGAPORE, TAIWAN, VIET NAAM, SOUTH AFRICA.

CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24. || The CADD Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump. || The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. || However, after attaching the reservoir to the pump, the user can still remove the || reservoir from the pump and prime it by holding the Flow Stop in the open position.