Z-0948-2019 Class II Terminated
FDA device recall Z-0948-2019 was initiated by Arrow International Inc on Oct 2, 2018 and is designated Class II. 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… The recall status is terminated (terminated Nov 12, 2021). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2019
- Initiation Date
- Oct 2, 2018
- Termination Date
- Nov 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, 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 Pattern
Nationwide distribution.
Code Information
74A1700874 74G1702797 74F1700146 74H1701106 74F1701964
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0948-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026