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Recall Observatory FDA recall evidence

Device product

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

Z-0946-2019

October 02, 2018

Class II

Product summary

Firm
Arrow International Inc
Event
Event 81375
Status
Terminated
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-0946-2019

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: 74A1701422 74G1702788 74B1700142 74M1600770 74C1701810 74M1601742 74G1702049 74M1602233

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.