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U.S. Department of Health and Human Services

Class 2 Device Recall CADD Medication Cassette Reservoirs

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 Class 2 Recall
CADD Medication Cassette Reservoirs
see related information
Date Posted February 13, 2008
Recall Status1 Open
Recall Number Z-0878-2008
Recall Event ID 46288
Premarket Notification
510(K) Number
K843772 
Product Classification Pump, Infusion - Product Code FRN
Product Smiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml, Reorder No.21-7100-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
Code Information 029X17/048/057/068/076/096/097/110/118.
Recalling Firm/
Manufacturer
Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 55112-6929
Manufacturer Reason
for Recall
Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action 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.
Quantity in Commerce 78, 792
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = DELTEC SYSTEMS, INC.
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