Z-1075-2014 Class II Terminated
FDA device recall Z-1075-2014 was initiated by Radiometer America Inc on July 5, 2013 and is designated Class II. Reason for recall: RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results. The recall status is terminated (terminated September 19, 2015). Affected quantity: 38,890 units (7,860 units imported into the US).
Recall Details
- Product Type
- Devices
- Report Date
- March 5, 2014
- Initiation Date
- July 5, 2013
- Termination Date
- September 19, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38,890 units (7,860 units imported into the US)
Product Description
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
Reason for Recall
RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY, and the countries of Bermuda and Canada.
Code Information
Model #: 942-063 Lot #'s: R338 to R493