Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks
Arrow International Inc is recalling specific 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 (cracks/leaks) could lead to reduced drug delivery and inadequate pain relief, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Arrow International Inc is recalling five units of the Arrow AutoFuser Disposable Pain Control Pump, product code MT8060XL CPNB. The recall involves units with the specific code information: 74A1801899, 74H1602701, 74B1700146, 74L1700201, and 74B1700921. The product was distributed nationwide.
The recall is due to 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.
Healthcare providers and patients should check their inventory and usage of these specific pump units. If a crack is observed, the pump should not be used. Users should contact Arrow International Inc for further instructions or replacement units.
The recalled product
- Product
- 0F 550 x 8ML/HR 2ML 60LO CPNB, Product code MT8060XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Pain Management
- Affected units
- 5
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)
- 74A1801899 74H1602701 74B1700146 74L1700201 74B1700921
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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