FDA Device recall Z-0954-2019
AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
- FDA Device
- Class II
- terminated
- Published 2019-03-06
On 2019-03-06 the FDA classified a Class II recall of AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump by Arrow International, citing 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 alt….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0954-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-02 |
| Published | 2019-03-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Arrow International |
| Distribution | US |
Product
AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
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.
Identifiers
| code_info | 74B1702339 74H1601294 74D1701102 74H1700162 74D1702253 74H1701109 74E1701025 74H1701794 74F1700780 74J1700192 74F1…74B1702339 74H1601294 74D1701102 74H1700162 74D1702253 74H1701109 74E1701025 74H1701794 74F1700780 74J1700192 74F1701946 74J1700678 74G1600394 74J1701748 74G1700546 74K1702039 74G1701177 74L1700931 74G1702054 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0954-2019%22
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