Z-0954-2019 Class II Terminated
FDA device recall Z-0954-2019 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: 19.
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
- 19
Product Description
AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-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
74B1702339 74H1601294 74D1701102 74H1700162 74D1702253 74H1701109 74E1701025 74H1701794 74F1700780 74J1700192 74F1701946 74J1700678 74G1600394 74J1701748 74G1700546 74K1702039 74G1701177 74L1700931 74G1702054
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0954-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026