Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog… — Class II medical device recall Z-0090-2018
Terminated recall by WalkMed, LLC, reported 2017-11-22, distributed nationwide. There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirmed to origina
| Recall number | Z-0090-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | WalkMed, LLC, Englewood, CO, United States |
| Recall initiated | 2017-09-27 |
| Classified | 2017-11-13 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2017-12-27 |
| Distributed | Nationwide (US) |
| Quantity | 25,920 bags |
| Reason classes | packaging |
| Model numbers | 150, 204820, 204821, IPR-150/10, IPR-86/10 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0090-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.