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Recall Observatory FDA recall evidence

Device product

AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP, Arrow AutoFuser Disposable Pain Control Pump

Z-0942-2019

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-0942-2019

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: 74A1801889 74H1700171 74F1700183 74H1701903 74F1701965 74H1703133 74F1702678 74K1700663

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.