Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks
Arrow International is recalling 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 defect that may result in reduced drug delivery and pain, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Arrow International Inc. is recalling the Arrow AutoFuser Disposable Pain Control Pump (Product code MVBT30XL CPNB) due to a potential defect in the fill port connector. The recall affects units with code 74H1701904 that were 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 and healthcare providers should check their inventory for the specific product code and contact Arrow International Inc. for further instructions or replacement units.
The recalled product
- Product
- AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL 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)
- 74H1701904
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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