Recall Z-0298-03 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .
| Date | Apr 3, 2003 (initiated Nov 7, 2002) |
| Status | Terminated |
| Reason | Heat exchanger may contain loose particulate matter |
| Root cause | Other |
| Action | Terumo Cardiovascular Systems notified customers by telephone on 11/8/02 by telephone, fax, and mail to advise distributors and end-users to cease use of the Heat Coil.. A follow-up letter issued to the accounts with instructions for the return of product. |
| Quantity | 10035 |
| Distribution | Nationwide. AR, CA, OH, FL, GA, IN, LA, MN, NJ, PA, TN, TX, WA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000977 | COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS Olson Medical Sales, Inc., Mar 23, 2001 |