Z-0940-2019 Class II Terminated
FDA device recall Z-0940-2019 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: 38.
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
- 38
Product Description
AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- 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
74A1801376 74G1702799 74A1801900 74H1700167 74A1802544 74H1701111 74B1700925 74H1701796 74C1701765 74H1702406 74D1700392 74J1700193 74D1701253 74J1700680 74D1701539 74J1701583 74D1702241 74J1702180 74E1700485 74J1702742 74E1701026 74K1700635 74E1701692 74K1701435 74E1702410 74K1702040 74F1700147 74K1702604 74F1701966 74L1700203 74F1702681 74L1700932 74F1703240 74L1702112 74G1700539 74M1700833 74G1701226 74M1701615
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0940-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026