BD Alaris Syringe Module includes non-validated compatible syringes in labeling
CareFusion is recalling 133,727 units of the BD Alaris Syringe Module because the labeling lists compatible syringes that have not been validated for use with the infusion pump.
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: This FDA Class I recall involves a labeling issue with potential impact on device function. No illnesses or injuries have been reported, and the hazard is theoretical rather than documented. Per the rubric, recalls without reported harm are classified as High rather than Severe.
Plain-English summary
The BD Alaris Syringe Module (REF 8110), manufactured by CareFusion 303, Inc., is being recalled by the FDA. The product's labeling includes a list of compatible syringes for use with the Alaris Patient Controlled Analgesia infusion pump. Some of these syringes listed as compatible have not been validated for use with the device.
This recall affects 133,727 units distributed worldwide, including throughout the United States and territories, as well as Canada, Germany, Italy, Japan, South Korea, Turkey, Australia, and other countries.
The use of non-validated syringes with the Alaris infusion pump could affect the device's proper functioning. No injuries or illnesses have been reported related to this issue.
Persons who have this device should review the product labeling to ensure only validated syringes are used. Questions about validated syringe compatibility should be directed to CareFusion or the FDA.
The recalled product
- Product
- BD Alaris Syringe Module, REF 8110
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- mis-labeling
- device-validation
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 (8)
- All Lots/ UDI-DI:10885403516047
- 10885403515323
- 10885403811043
- 10885403515255 10885403811036
- 10885403515262
- 10885403811012
- 10885403515279
- 10885403424267
Distribution
Distributed nationwide across the United States.
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