Z-0953-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2019
- Initiation Date
- October 2, 2018
- Termination Date
- November 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, 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
74M1500647 74G1702789