Z-0951-2019 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
- 8
Product Description
AF 550x8ML/H 2ML 15LO 8.7" DUAL CATHS, 4, Product code MT8015XLYK10 CP, 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
74A1701382 74H1701147 74B1602450 74J1600057 74B1701726 74L1601123 74F1701975 74L1702110