Health product recall

Terumo Cardiovascular Procedure Kits

Last updated

Summary

Product
Terumo Cardiovascular Procedure Kits
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Cardiovascular Procedure Kit (Cardioplegia Set)

More than 10 numbers, contact manufacturer.

75956

Terumo Cardiovascular Procedure Kit (X-Coated Perfusion Pack) Ter-75956

0000450281

75797

Issue

CHS initiated this recall after receiving a notification from Terumo on their cardiovascular procedure kits that include high crack check valve. Terumo cardiovascular systems (Terumo CVS) has received six complaints whereby the pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmhg versus 400mmhg.

Recall start date: February 26, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Terumo Cardiovascular Costa Rica, Llc
Calle 58, Cartago, Costa Rica, 30106
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75310

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