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 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, fitting the 'High' severity criteria.
Plain-English summary
Arrow International Inc. is recalling specific units of the Arrow AutoFuser Disposable Pain Control Pump. The recall involves product code MC0050XLYK2 CP, with a quantity of 5 units affected. The products were distributed nationwide.
The recall is being issued because of 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 the affected product codes. If a leak is observed, the pump should not be used, and an alternative should be sought.
The recalled product
- Product
- AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, 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)
- 74B1700141 74K1602023 74J1601147 74L1602735 74J1602863
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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