Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.
This recall has been terminated (originally issued May 11, 2016).
- Recall Initiated
- May 11, 2016
- Terminated
- April 27, 2018
- Recall Number
- Z-2087-2016
- Quantity
- 487
- Firm Location
- Brookfield, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Premature bucket failures
Distribution
Nationwide: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV.
Lot / Code Info
All serial numbers are affected.
Root Cause
Under Investigation by firm
Action Taken
Siemens mailed to customers an Urgent Medical Device Correction (UMDC#LAI16-02.A.US) Urgent Field Safety Notification letter informing customers of the problem with recommendations to follow the existing maintenance instructions in the product operator manuals as well as a new requirement to spin at cycle speeds not exceeding 3500 rpm.
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