Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .
FDA Recall Z-0298-03 · Posted 2003-04-03
Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTR
Date Initiated2002-11-07
Date Terminated2015-08-06
Product Quantity10035
Reason for Recall
Heat exchanger may contain loose particulate matter
Firm Action
Terumo Cardiovascular Systems notified customers by telephone on 11/8/02 by telephone, fax, and mail to advise distributors and end-users to cease use of the Heat Coil.. A follow-up letter issued to the accounts with instructions for the return of product.
Root Cause
Other
Distribution Pattern
Nationwide. AR, CA, OH, FL, GA, IN, LA, MN, NJ, PA, TN, TX, WA, WI
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.