Recall Z-2101-2014 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena
| Date | Jul 23, 2014 (initiated May 23, 2014) |
| Status | Terminated |
| Reason | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications |
| Root cause | Process control |
| Action | Terumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow |
| Quantity | 3,040 units |
| Distribution | Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, 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, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Bel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K875048 | SARNS VENOATRIAL CATHETER 3M Health Care, Sarns, Feb 18, 1988 |