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
This recall has been terminated (originally issued September 18, 2015).
- Recall Initiated
- August 24, 2015
- Posted
- September 18, 2015
- Terminated
- February 5, 2016
- Recall Number
- Z-2788-2015
- Quantity
- 30 kits
- Firm Location
- Ashland, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
Distribution
Nationwide Distribution including CA, CT , FL , WI.
Lot / Code Info
Lot Numbers: TD02, TD16
Root Cause
Nonconforming Material/Component
Action Taken
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.