CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- February 2, 2015
- Posted
- March 17, 2015
- Terminated
- March 18, 2016
- Recall Number
- Z-1286-2015
- Quantity
- 48,208 (17,040 US, 31,168 OUS).
- Firm Location
- Saint Paul, MN
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.
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.
Lot / Code Info
21-7001-24: Lots 14X297 and 14X323 21-7301-24 (Flow Stop): Lot 14X324
Root Cause
Under Investigation by firm
Action Taken
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.