Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Leaks
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 is classified as FDA Class II and involves a risk of reduced drug delivery and pain relief, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Arrow International Inc. is recalling the Arrow AutoFuser Disposable Pain Control Pump, product code MVBX60XL CPNB, due to a potential defect in the fill port connector. The recall is classified as Class II by the U.S. Food and Drug Administration.
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 necessitate the administration of other, additional analgesic drugs.
The product was distributed nationwide. Users should check their pumps for cracks on the fill port connector and contact the manufacturer or their healthcare provider for guidance if a defect is found.
The recalled product
- Product
- AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Pain Management
- Affected units
- 1
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)
- 74E1702443
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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