CDI Blood Parameter Monitoring System 500 with Arterial recall: Software Issue
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures…
Why was CDI Blood Parameter Monitoring System 500 with Arterial recalled?
Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number: 500AV* and serial numbers: 0024, 0033, 0040, 0051, 1192, 1193, 1355,1356, 1420, 1423, 1464, 1465, 1467, 1468,1483,1504,1521-1524,1526,1527,1529,1530, 1602-1604, 1606, 1662, 2023, 2035, 2102-2107, 2800, 2901,2902, 3131-3135, 3261, 3262, 4132, 5330-5333, 5338-5340, 5578, and 5579.
- Product
- CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 3972 since 4/26/12
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico 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, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.
- Recall date
- July 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)