FDA-Device2019-03-06Class II
AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, 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
9
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser Disposable Pain Control Pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0949-2019Don't want to check this manually?
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