Device product
Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL The WalkMed Reservoir Bag is designed for use with the WalkMed 350VL Ambulatory pump and is intended to be used as a reservoir and fluid path for administering intravenous, subcutaneous, arterial, enteral, and epidural infusions of antibiotics, analgesics, chemotherapeutic agents, and other medications or fluids. Please note that the WalkMed 350VL pump is contraindicated for: Infusion of blood and blood products, Infusion of insulin, Infusion of critical medications whose stoppage or interruption would cause serious injury or death Use in ambulatory regimens by patients who do not possess the mental, physical, or emotional capability to operate the pump properly; or who are not under the care of a responsible individual.
Z-0090-2018
Product summary
- Firm
- WalkMed, LLC
- Event
- Event 78302
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,920 bags
- Official record key
device-enforcement:Z-0090-2018
Official wording
Reason: There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirmed to originate from, or near, the reservoirs clearcolored female luer connecter.
Code information: 20717525, 20717529, 20817502, 20817503, 20717509, 20717511, 20717512, 20717517, 20817500, 20717530
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirmed to originate from, or near, the reservoirs clearcolored female luer connecter.