Cardiovascular Custom Procedure Kits, REV.OB PERFUSION W/8:1 CARDIOPLEGIA Item Number: 71653-04 Terumo Cardiovascular Sy
FDA device recall Z-3230-2011 · posted 2011-09-16 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- 3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at the bond that holds the two halves
- Action taken
- Terumo Cardiovascular Systems initiated contact on August 12, 2011 by phone, fax, email and Urgent: Medical Device Recall mail to all affected customers. The firm advised customers of the affected product, problem and required recall actions. Customers can remove whole customized packs that are not in urgent medical need and return packs. Or the User may opt to use a sterile LH 130 vent valve from Terumo Cardiovascular Systems. A response form was included to return back to the firm. For questions on this recall contact Terumo Customer Service at (734) 525-9580.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MJJ
- Quantity affected
- 25 units
- Distribution
- Nationwide Distribution, including the states of FL and MI.
- Date initiated
- 2011-08-11
- Date posted
- 2011-09-16
- Date terminated
- 2012-03-20
- 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 |
|---|---|---|
| 3T L. V. CONTROL VALVE (K001245) | 3t Medical Systems, LLC | 2001-08-15 |