Heater Cooler Unit Usage: The Heater-Cooler Unit recall: Contamination
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat…
Why was Heater Cooler Unit Usage: The Heater-Cooler Unit recalled?
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653 HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.
- Product
- Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat…
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 305 units
- Distribution
- Worldwide Distribution - US Nationwide
- Recall date
- November 9, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)