Terumo Cardiovascular Procedure Kits
Last updated
Summary
Product
Terumo Cardiovascular Procedure Kits
Issue
Medical devices - Performance
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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