Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks
Arrow International is recalling 8 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.
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 involves a medical device where a defect (cracks/leaks) could lead to reduced drug delivery and inadequate pain relief, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 8 units of the Arrow AutoFuser Disposable Pain Control Pump, product code MC0050XLYK5 CP. The recall involves the AF 550 x 5ML/H 6" DUAL CATHS, 4.5" model. The product was distributed nationwide.
The recall is being conducted because of 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 and consequently a lower level of pain relief than prescribed or expected. This may result in the need for other, additional analgesic drug administration.
Users should check their devices for cracks on the fill port connector. If a crack is found, the device should not be used, and the user should contact the manufacturer for a replacement or further instructions.
The recalled product
- Product
- AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Pain Management
- Affected units
- 8
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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