Recall Z-2261-2013 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Terumo Cardiovascular Systems Corporation
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns i
| Date | Sep 20, 2013 (initiated Jul 26, 2013) |
| Status | Terminated |
| Reason | Medical device used in cardiovascular procedures is defective. |
| Root cause | Nonconforming Material/Component |
| Action | Terumo Cardiovascuolar Services sent recall letters to Chief of Perfusion, Director of Operating Room Services, Director of Biomedical Services, and Risk Management departments on July 26, 2013. The notifications advised that filters are being recalled because some of the filters may exhibit a partial or full occlusion of an outlet or purge port. Terumo CVS advised users to stop using Terumo AL6X arterial filters from the affected lot numbers for replacement. A supply of replacement filters for customer's immediate use accompanied the notification. For users ordering the AL6X filters as part o |
| Quantity | 15,817 filters |
| Distribution | Nationwide Distribution including WA, IN, OK, TX, MI, CA, NY, CT, AZ, FL, WV, NC, VA, PA, TN, GA, AL, MA, SC, OH, MS, MO, SD, WI, AR, AND NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.