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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 Device Recall CADD Medication Cassette Reservoirs see related information
Date Initiated by Firm December 14, 2007
Date Posted February 13, 2008
Recall Status1 Terminated 3 on January 11, 2011
Recall Number Z-0879-2008
Recall Event ID 46288
510(K)Number K040636  
Product Classification Medication Cassette Reservoirs - Product Code FPA
Product 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
Code Information 061X17
Recalling Firm/
Manufacturer		 Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact
651-628-7280
Manufacturer Reason
for Recall		 Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps
FDA Determined
Cause 2		 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 4,644
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = SMITHS MEDICAL MD, INC.
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