Recall record at a glance
| Official record | Z-0090-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | WalkMed, LLC |
| Report date | Nov 22, 2017 |
| Recall initiation date | Sep 27, 2017 |
| Quantity | 25,920 bags |
| Location | Englewood, CO, United States |
Official product description
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.
Why the product was recalled
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 information
Nationwide Distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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