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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Cardiovascular Systems (CVS)

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  Class 2 Device Recall Terumo Cardiovascular Systems (CVS) see related information
Date Initiated by Firm August 24, 2015
Date Posted September 18, 2015
Recall Status1 Terminated 3 on February 05, 2016
Recall Number Z-2788-2015
Recall Event ID 72010
Product Classification unknown device name - Product Code N/A
Product Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE
P/N: 7928-03
Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
Code Information Lot Numbers: TD02, TD16
Recalling Firm/
Terumo Cardiovascular Systems Corp
28 Howe St
Ashland MA 01721-1305
Manufacturer Reason
for Recall
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
FDA Determined
Cause 2
Nonconforming Material/Component
Action Terumo CVS issued an Urgent Medical Device Recall Notice dated August 24, 2015, to consignees via express mail. The letter advised users to immediately quarantine affected Cardiovascular Procedure Kits and stop using the Hemocor HPH700 Hemoconcentrator within the kit. Replacement sterile, stand-alone Hemocor HPH700 Hemoconcentrators will accompany the letter so that users may replace the affected emoconcentrators at the point of use. The option of replacing the hemoconcentrator at the point of use is offered to facilitate imminently scheduled cardiopulmonary bypass procedures. Users are requested to return the unused hemoconcentrators to Terumo CVS. Alternatively, users may return the entire Cardiovascular Procedure Kit to Terumo CVS for replacement. Customers with questions were instructed to call 763-553-3348.
Quantity in Commerce 30 kits
Distribution Nationwide Distribution including CA, CT , FL , WI.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.