FDA recall Z-0946-2019

Product

AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFuser Disposable Pain Control Pump

Reason for recall

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.

Distribution

Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2018-10-02

Report date

2019-03-06

Termination date

2021-11-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0946-2019