Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK Product Code: 71062-01 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
Recall
- Recall Number
- Z-1530-2012
- Event Number
- 61644
- Firm
- Terumo Cardiovascular Systems Corp
- FEI Number
- 1000149028
- Product Code
- DTZ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 12, 2012
- Posted
- May 11, 2012
- Terminated
- January 23, 2013
- Address
- 28 Howe St, Ashland, MA, 01721-1305
Description
Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK Product Code: 71062-01 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
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 [email protected]
Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada.
37 units