Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0940-2019 — AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump

U.S. FDA — Device Enforcement · United States · 2018-10-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0940-2019
Date of alert
2018-10-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Arrow International Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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