RecallDepth

Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112

Company
Smiths Medical Md, Inc.
Recall Initiated
December 14, 2007
Posted
February 13, 2008
Terminated
January 11, 2011
Recall Number
Z-0879-2008
Quantity
4,644
Firm Location
Saint Paul, MN

Reason for Recall

Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps

Distribution

Worldwide Distribution --- USA including states of AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND,NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, and countries of AN, AR, AU, BR, CA, CL, CN, CZ, DK, EE, ES, FI, FR, GB, GR, HK, HU, IE, IL, IT, JO, JP, KW, LB, MY, NL, NO, PA, PL, PT, SA, SE, SG, TAIWAN, TH, VI, ZA, CH, AT, and BE.

Lot / Code Info

061X17

Root Cause

Process control

Action Taken

Consignees were mailed the recall letters on December 21,2007. The recalled letter "Smiths Mecical Urgent Product Recall Notification" makes them aware of the potential issue. Customers will be requiired to return the affected devices to Smiths Medical.

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