FDA Device recall Z-0950-2019
AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL 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 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL 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-0950-2019 |
| 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 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL 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 | 74B1602449 |
|---|
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-0950-2019%22
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