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

FDA device recall Z-2789-2015 · posted 2015-09-18 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corp

Reason for recall

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

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

N/A

Quantity affected

6 kits

Distribution

Nationwide Distribution including CA, CT , FL , WI.

Date initiated

2015-08-24

Date posted

2015-09-18

Date terminated

2016-02-05

Location

Ashland, MA