Sorin Recalls Stockert Heater-Cooler 3T Units for Instruction Manual Updates
Sorin Group USA is recalling 1,125 Stockert Heater-Cooler 3T units to update instruction manuals with water quality enhancements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II but involves documentation updates (IFU) rather than a structural defect or reported harm, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
Sorin Group USA, Inc. is recalling 1,125 units of the Stockert Heater-Cooler 3T (Item Numbers 16-02-8, 16-02-82, and 16-02-85). The recall covers devices distributed worldwide, including US nationwide and VA/government/military facilities.
The recall was initiated to update the Instruction for Use (IFU) to Version 12. The revised manual includes enhancements to achieve water quality that meets the standard for German drinking water. Sorin informed consignees of these changes via letter on August 15, 2012.
This action is classified as an FDA Class II recall. The source text does not report any specific illnesses or injuries associated with the device.
The recalled product
- 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
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 1,125
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All Serial Numbers for Item Number 16-02-81
- 16-02-82
- 16-02-85
Distribution
Distributed nationwide across the United States.
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