FDA-Device2019-03-06Class II
AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Arrow International Inc
Hazard
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.
Sold states
Nationwide distribution.
Affected count
8
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0946-2019Don't want to check this manually?
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