Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended FX15RE40 PACK Product Code:66031
This recall has been terminated (originally issued May 11, 2012).
- Recall Initiated
- April 12, 2012
- Posted
- May 11, 2012
- Terminated
- January 23, 2013
- Recall Number
- Z-1525-2012
- Quantity
- 170 units
- Firm Location
- Ashland, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Distribution
Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada.
Lot / Code Info
Lot Nos: NH05; NH11; NM10 ; NP12 ; PA02 ; PC27
Root Cause
Nonconforming Material/Component
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