Arrow AutoFuser Pain Control Pump Recalled for Potential Cracks
Arrow International is recalling specific 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) can lead to reduced drug delivery and inadequate pain relief, representing a risk of harm 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/H 6" CATH, 4.5" IN model with product code MC0050XLSK5 CP. 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. This can lead to a lower level of pain relief than prescribed or expected, potentially requiring the administration of other, additional analgesic drugs.
The product was distributed nationwide. Users should check their devices for cracks on the fill port connector and contact the manufacturer for instructions if a defect is found.
The recalled product
- Product
- AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, 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)
- 74J1601025
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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