FDA (Devices) recall action 81375
The FDA (Devices) publishes a recall like this one as 17 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 17 pages.
Possible cracks on the body of the fill port connector, which may result in a leak. If the 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 and consequently a lower level of pain relief than that prescribed or expected. This may result in the need for other, additional analgesic drug administration.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Arrow International is recalling 8 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.
Arrow International is recalling 19 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.
Arrow International Inc. is recalling Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.
Arrow International Inc. is recalling Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.
Arrow International is recalling AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.
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.
Arrow International is recalling specific AutoFuser pumps due to possible cracks in the fill port connector that may cause leaks and reduced drug delivery.
Arrow International is recalling specific AutoFuser pumps due to possible cracks in the fill port connector that could cause leaks and reduced drug delivery.
Arrow International is recalling 26 units of the AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.
Arrow International Inc is recalling specific Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.
Arrow International is recalling specific AutoFuser pumps due to possible cracks in the fill port connector that may cause leaks and reduced drug delivery.
Arrow International Inc. is recalling 8 units of the Arrow AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.
Arrow International Inc. is recalling 9 units of the Arrow AutoFuser Disposable Pain Control Pump due to possible cracks on the fill port connector that may cause leaks.
Arrow International is recalling specific AutoFuser pumps due to possible cracks in the fill port connector that could cause leaks and reduced drug delivery.
Arrow International is recalling 38 units of the Arrow AutoFuser Disposable Pain Control Pump due to possible cracks that may cause leaks and reduced drug delivery.
Arrow International Inc. is recalling specific Arrow AutoFuser Disposable Pain Control Pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.
Arrow International is recalling specific AutoFuser pumps due to possible cracks on the fill port connector that may cause leaks and reduced drug delivery.