Arrow AutoFuser Disposable Pain Control Pump Recalled for Potential Leaks
Arrow International is recalling specific AutoFuser pumps due to possible cracks in 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 defect that may result in 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 the Arrow AutoFuser Disposable Pain Control Pump (Product MT5060XLYK5 CP) due to a potential defect in the fill port connector. The recall affects 3 units with specific lot codes 74F1700794, 74J1700676, and 74J1700190 that were distributed nationwide.
The recall is being conducted because possible cracks on the body of the fill port connector may result in a leak. If a leak is identified while the user is filling the pump, 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.
Users of the affected pumps should check their product codes against the listed codes. If the product matches the recalled items, they should stop using the pump and contact Arrow International Inc for further instructions.
The recalled product
- Product
- AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Pain Management
- Affected units
- 3
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)
- 74F1700794 74J1700676 74J1700190
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.
See all 17 products in this recall →Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · leak
See all →- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighAnti-siphon smallbore extension sets recalled over port weld separation risk
FDA (Devices) · 2025-11-05