medical Class II Updated 2019-03-06

Arrow International Inc recalls AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT801

Recalled Product

AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, 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: 74A1701382 74H1701147 74B1602450 74J1600057 74B1701726 74L1601123 74F1701975 74L1702110
View official government recall

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