Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Cracks
Arrow International is recalling specific AutoFuser pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the hazard involves a risk of harm (reduced drug delivery) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Arrow International Inc is recalling the Arrow AutoFuser Disposable Pain Control Pump (Product code MT8015XLYK10 CP) due to a potential defect in the fill port connector. The recall involves units with specific lot codes 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 during the filling process, it may cause 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 lower pain relief than prescribed or expected. This may necessitate the administration of additional analgesic drugs.
Healthcare providers and patients should check their inventory and usage of these specific pumps. If a leak is observed, the pump should not be used, and an alternative should be sought to ensure proper pain management.
The recalled product
- Product
- AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, Arrow AutoFuser Disposable Pain Control Pump
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Pain Management
- Affected units
- 8
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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