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U.S. Department of Health and Human Services

Class 2 Device Recall CADD" Medication Cassette Reservoir, 50mL

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  Class 2 Device Recall CADD" Medication Cassette Reservoir, 50mL see related information
Date Initiated by Firm February 02, 2015
Date Posted March 17, 2015
Recall Status1 Terminated 3 on March 18, 2016
Recall Number Z-1286-2015
Recall Event ID 70402
510(K)Number K843772  K040636  
Product Classification Set, administration, intravascular - Product Code FPA
Product CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
Code Information 21-7001-24: Lots 14X297 and 14X323 21-7301-24 (Flow Stop): Lot 14X324
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact Customer Service
800-258-5361
Manufacturer Reason
for Recall		 Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (Cassette). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.
FDA Determined
Cause 2		 Under Investigation by firm
Action Smiths Medical sent an "Urgent Medical Device Recall" letter dated February 2, 2015, to all affected customers. The letter was addressed to Risk Safety Manger, Biomedical Professionals, Clinicians who oversee the use of CADD pumps, Distributors, and other users of these devices. The letter described the problem and the product involved in the recall. The letter also addressed the "Advice on Action to be Taken by the User", and "Transmission of this Urgent Recall Notice". Customers were requested to complete and return the Confirmation Form by Fax to 1-800-237-8033 or be email to recall.response@smiths-medical. For issues with these products they can contact Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcompaints@smiths-medical.com. For questions on the information provided they can contact Customer Service Department at 1-800-258-5361.
Quantity in Commerce 48,208 (17,040 US, 31,168 OUS).
Distribution Worldwide Distribution - US (nationwide) Distribution to the states of : AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL IN, IA, MD, MA, MN, MS, MO, NE, NV, NH ,NJ, NM, NY, NC, OH, OR, PA, SD, TN, TX, UT, VA and WA., and to the countries of : Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic, Germany, Denmark, Spain. Finland, France, United Kingdom (GB) Hungary, Indonesia, Ireland, Italy, Netherlands, Portugal, Sweden, Singapore and South Africa.
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 = DELTEC SYSTEMS, INC.
510(K)s with Product Code = FPA and Original Applicant = SMITHS MEDICAL MD, INC.
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