Recall Z-1299-2012 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Sarns Soft-Flow Aortic Cannula without suture flange Angled tip 8.0mm (24Fr) 0D with 3/8" connector, 12" (31cm) long Product Usage: CTS Usage: The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary byp
| Date | Mar 23, 2012 (initiated Feb 23, 2012) |
| Status | Terminated |
| Reason | During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball. |
| Root cause | Nonconforming Material/Component |
| Action | Terumo sent an URGENT MEDICAL DEVICE RECALL letter dated February 23, 2012 via Federal Express to all US customers. Terumo Foreign Affiliates received the recall notification via email on February 24th, 2012. The letters identified the affected products, reson for removal, potential hazard, affected population and actions to be taken. Customers were instructed to review the Medical Device Removal notice, assure that all users are aware of the notice, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number provided or email to tcvs.recall@terumome |
| Quantity | 188,282 Cannulae and 248 Custom Tubing Packs |
| Distribution | USA Nationwide Distribution including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of: CANADA, CHILE, India, Japan, Singapore, AUSTR |
| FDA record | Open on fda.gov |