Stockert Heater-Cooler 3T recall
Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
Why was Stockert Heater-Cooler 3T recalled?
On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.
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?
All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85;
- Product
- Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
- Recalling firm
- Sorin Group USA, Inc.
- Quantity
- 1125 units
- Distribution
- Worldwide Distribution - US Nationwide, VA/govt/military
- Recall date
- March 23, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)