Recall Z-1459-2017 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
| Date | Mar 14, 2017 (initiated Feb 20, 2017) |
| Status | Terminated |
| Reason | Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users. |
| Root cause | Under Investigation by firm |
| Action | Terumo CVS initiated a voluntary recall by issuing a safety advisory for their Terumo Advanced Perfusion System 1-Level Sensor II Pads, and Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users. Customers are asked to do the following: 1. Review the Safety Advisory. 2. Assure that all users receive notice of this issue. 3. Confirm receipt of this Safety Advisory by emailing or faxing the attached Customer Response Form to the email address or fax number in |
| Quantity | 3,794 |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of: Mexico, AUSTRALIA, UNITED ARAB EMIRATES (UAE), Indonesia, Singapor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153376 | Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation, Dec 16, 2015 |