Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15 ADULT PACK Product Code: 73399
FDA Recall Z-1527-2012 · Posted 2012-05-11
Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTZ
Date Initiated2012-04-12
Date Terminated2013-01-23
Product Quantity10 units
Reason for Recall
Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss
Firm Action
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]
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.