Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks
Arrow International Inc. is recalling Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector 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 involves a medical device where a defect (leak) may result in reduced drug delivery and lower pain relief, representing a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Arrow International Inc. is recalling Arrow AutoFuser Disposable Pain Control Pumps, product code MVAX30XL CPNB, due to possible cracks on the body of the fill port connector. The affected products were distributed nationwide.
The cracks may result in a leak. If the 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 that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
The source text does not specify specific actions for consumers or healthcare providers beyond the description of the defect and its potential consequences.
The recalled product
- Product
- AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Pain Management
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)
- 74F1700085 74F1703357
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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