AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump
Published March 6, 2019 · Recall initiated: October 2, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- Nationwide distribution.
- Lot
- 74B1702339 74H1601294 74D1701102 74H1700162 74D1702253 74H1701109 74E1701025 74H1701794 74F1700780 74J1700192 74F1701946 74J1700678 74G1600394 74J1701748 74G1700546 74K1702039 74G1701177 74L1700931 74G1702054
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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