FDA recall Z-0090-2018

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.

Reason for recall

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.

Distribution

Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-09-27

Report date

2017-11-22

Termination date

2017-12-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0090-2018