medical Class II Updated 2019-03-06

Arrow International Inc recalls AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2

Recalled Product

AF w/AS 550 x 0.5-7 ml,w/Y site,DL CPNB, Product code MVAXL2Y CPNB, Arrow AutoFuser Disposable Pain Control Pump


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 74A1600493 74E1701689 74A1701278 74F1601947 74B1700147 74G1601342 74B1700922 74H1601292 74C1601403 74H1602005 74C1601458 74J1601528 74C1601839 74K1601040 74C1602928 74K1601957 74C1702397 74L1601996 74D1600766 74L1602670 74E1600739 74M1501120 74E1601599 74M1600311 74E1700481 74M1600671
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