Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .
FDA device recall Z-0298-03 · posted 2003-04-03 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Heat exchanger may contain loose particulate matter
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTR
- Quantity affected
- 10035
- Distribution
- Nationwide. AR, CA, OH, FL, GA, IN, LA, MN, NJ, PA, TN, TX, WA, WI
- Date initiated
- 2002-11-07
- Date posted
- 2003-04-03
- Date terminated
- 2015-08-06
- Location
- Ashland, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS (K000977) | Olson Medical Sales, Inc. | 2001-03-23 |