Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Leaks
Arrow International is recalling 38 units of the Arrow AutoFuser Disposable Pain Control Pump due to possible cracks that may cause leaks and reduced drug delivery.
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 risk of harm (reduced drug delivery) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Arrow International Inc is recalling 38 units of the Arrow AutoFuser Disposable Pain Control Pump (Product code MVBXL- CPNB) due to a potential defect in the fill port connector. The recall covers units distributed nationwide.
The defect involves possible cracks on the body of the fill port connector, which may result in a leak. If a leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected, it may result in a reduced level of drug delivery to the patient, leading to a lower level of pain relief than prescribed or expected. This may result in the need for other, additional analgesic drug administration.
Consumers should check their devices for the specific lot codes listed in the official recall notice and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Pain Management
- Affected units
- 38
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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