—#139620

Product

Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 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

FDA product code: N/A
Affected lot / code info: Lot Numbers: TD02

Why it was recalled

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 28 Howe St, Ashland, Massachusetts 01721-1305

Distribution

Distribution pattern: Nationwide Distribution including CA, CT , FL , WI.

Timeline

Recall initiated: 2015-08-24
Posted by FDA: 2015-09-18
Terminated: 2016-02-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139620. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.