Sorin S5 Heart-Lung Machine Recalled for Power Supply Failure Risk
Sorin Group USA is recalling 5,264 Stöckert S5 Heart-Lung Machines worldwide due to a potential failure of the Uninterruptible Power Supply.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device used in critical surgical procedures. While no injuries are reported, the potential for power failure during cardiopulmonary bypass presents a significant risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sorin Group USA, Inc. is initiating a field correction for the Stöckert S5 System, specifically the S5 Heart-lung machine and cardiopulmonary bypass heart-lung machine console. The recall involves 5,264 units distributed worldwide, including in the United States and various international locations. The devices are intended for use during cardiopulmonary bypass procedures lasting six hours or less and come into direct contact with the central circulatory system.
The recall is being conducted because of the potential for failure of the Uninterruptible Power Supply (UPS) in the affected machines. The source text does not report any specific injuries, illnesses, or deaths associated with this defect. The recall is classified as Class II by the U.S. Food and Drug Administration.
Affected units are identified by specific Item Numbers (48-30-00, 48-40-00, 48-50-00, and 58-00-00) and a list of serial numbers provided in the official recall notice. Healthcare facilities and users should verify their equipment against the provided serial numbers and contact the recalling firm for instructions on the field correction.
The recalled product
- Product
- St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 5,264
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 (20)
- Item No.: 48-30-00 Serial No: 28E24640
- 28E24651
- 28E24642
- 28E24674
- 28E24657
- 28E24652
- 28E24671
- 28E24675
- 28E24676
- 28E24678
- 28E24670 Item No 48-40-00 Serial No: 28E24644
- 28E24641
- 28E24648
- 28E24661
- 28E24643
- 28E24650
- 28E24677
- 28E24659
- 28E24658
- 28E24672
Distribution
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