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Recall Observatory FDA recall evidence

Device product

AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump

Z-0947-2019

October 02, 2018

Class II

Product summary

Firm
Arrow International Inc
Event
Event 81375
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-0947-2019

Official wording

Reason: 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.

Code information: 74B1700141 74K1602023 74J1601147 74L1602735 74J1602863

Distribution pattern: Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.