Z-1286-2015 Class II Terminated
FDA device recall Z-1286-2015 was initiated by Smiths Medical ASD, Inc. on Feb 2, 2015 and is designated Class II. 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… The recall status is terminated (terminated Mar 18, 2016). Affected quantity: 48,208 (17,040 US, 31,168 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 25, 2015
- Initiation Date
- Feb 2, 2015
- Termination Date
- Mar 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,208 (17,040 US, 31,168 OUS).
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1286-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026