Bard Intra-abdominal Pressure Monitoring Device Recalled for Potential Leaks
C.R. Bard Inc. is recalling 1,300 units of the Bard Intra-abdominal Pressure Monitoring Device due to leaks or disconnects that may cause inaccurate readings.
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 the source text explicitly states no illnesses or injuries have been reported. The hazard is limited to inaccurate readings, which fits the criteria for a moderate severity score involving low-risk issues or theoretical hazards without reported harm.
Plain-English summary
C.R. Bard Inc. is recalling 1,300 units of the Bard Intra-abdominal Pressure Monitoring Device. The device is a tubing set used to infuse fluid into the urinary bladder through a Foley catheter sampling port to measure intra-abdominal pressure. The recall involves Product Code IAP001, specifically lot numbers NGDQ2943 and NGDS0622.
The recall is being issued because of leaks or disconnects near the sampling port, which could lead to inaccurate pressure readings. The source text does not report any illnesses, injuries, or deaths associated with this defect.
The affected devices were distributed nationwide, including Washington DC and Guaynabo, Puerto Rico, as well as to Belgium and Japan. The source text does not provide specific instructions for consumers or healthcare providers on how to return the devices, but it notes that measurements should be confirmed with other means, such as a new IAP system or alternative diagnostic options, to ensure accuracy.
The recalled product
- Product
- The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pre
- Manufacturer
- C.R. Bard Inc
- Hazard
- Affected units
- 1,300
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 (1)
- Product Code IAP001 lot numbers NGDQ2943 and NGDS0622.
Distribution
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