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Terminated

CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.

FDA Recall Z-1286-2015 · Posted 2015-03-17

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2015-02-02
Date Terminated2016-03-18
Product Quantity48,208 (17,040 US, 31,168 OUS).

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.

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 [email protected]. For questions on the information provided they can contact Customer Service Department at 1-800-258-5361.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040636CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SETSmiths Medical MD, Inc. · 2004-05-19K843772CADD-1 5100 AMBULATORY INFUSION PUMPDeltec Systems, Inc. · 1984-12-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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