Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks
Arrow International is recalling specific AutoFuser pumps due to possible cracks in the fill port connector that could 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 fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling the Arrow AutoFuser Disposable Pain Control Pump, specifically the AF 550 x 5ML/HR 2ML 60LO CPNB model (Product code MT5060XL CPNB). 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.
The affected products were distributed nationwide. Users should check their devices for the specific product code and lot numbers listed in the official recall notice to determine if they are affected.
The recalled product
- Product
- AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL 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)
- 74A1700874 74G1702797 74F1700146 74H1701106 74F1701964
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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