Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml., Reorder No. 21-7002-24 , 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-0877-2008
- Quantity
- 865,824
- 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
023X17- 027/031-034/040-042/044/046/047/051/052/054/055/058/059/063-065/067/069/071/073/075/077/078/080/081/084-086/088/089/093/095/099-101/108/114-117/119-122.
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.