Terumo Custom Cardiovascular Procedure Kit-: CUSTOM X-COATED LOW PRIME Product Code:72015-03 Manufactured to the design
FDA device recall Z-1531-2012 · posted 2012-05-11 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
- Action taken
- Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or tcvs.recall@teruomedical.com
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 215 units
- Distribution
- Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada.
- Date initiated
- 2012-04-12
- Date posted
- 2012-05-11
- Date terminated
- 2013-01-23
- 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 |
|---|---|---|
| CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER (K071494) | Terumo Corp. | 2007-07-16 |