Bubble Sensor for CARDIOHELP-i system has incorrect device identifier on label
Maquet Medical Systems is recalling the Bubble Sensor accessory for CARDIOHELP-i extracorporeal life support systems due to an incorrect UDI Device Identifier printed on the product label.
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: FDA Class II labeling error with no reported illnesses, injuries, or safety incidents. This is a minor labeling issue affecting device identification and traceability rather than direct patient safety hazard.
Plain-English summary
The Bubble Sensor (REF: 70105.5720) is an optional accessory to the CARDIOHELP-i extracorporeal life support system manufactured by Maquet Medical Systems USA. The device is being recalled due to an incorrect UDI Device Identifier (DI) printed on the product label.
The label on affected units displays an incorrect UDI DI of 04058863025148, when the correct UDI DI should be 04037691816432. This labeling error affects 274 units total, with 70 units distributed in the United States and 204 units distributed outside the United States. Affected units were distributed to healthcare facilities in Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Minnesota, Nebraska, Pennsylvania, Texas, Washington, and Wisconsin.
Healthcare facilities that received this device should verify their inventory using the provided serial numbers. If you have an affected unit, contact Maquet Medical Systems USA immediately.
The recalled product
- Product
- Bubble Sensor (REF: 70105.5720)
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- mis-labeling
- device-identification
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)
- Model: BS 3/8x3/32 L1.7
- Correct UDI DI: 04037691816432
- Incorrect UDI DI (as labeled): 04058863025148
Distribution
Distributed in 13 states:
- AZ
- CA
- CO
- FL
- GA
- IA
- IL
- MN
- NE
- PA
- TX
- WA
- WI
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