Z-0090-2018Class II

Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag...

Name: Z-0090-2018 Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag...
Creator: WalkMed, LLC
Published: 2017-09-27
License: https://open.fda.gov/license/

WalkMed Technologies, LLC / initiated 2017-09-27 / Terminated / root cause: manufacturing process

FDA source

WalkMed, LLC began a recall of 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... on 2017-09-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0090-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-27
Posted: 2017-11-13
Terminated: 2017-12-27
Recalling firm: WalkMed Technologies, LLC
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.
Product code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: WalkMed sent an Urgent Medical Device Recall letter dated September 27, 2017, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: discontinue distribution of any affected products. Contact any customers to whom these products were dispensed and inform the customers accordingly based on the following items. Wear gloves and other personal protective equipment as needed to avoid contact with leaking infusion fluids when handling the product. Collect and return affected products using proper biohazardous material handling where applicable. Complete the enclosed Acknowledgement Form to record the return or destruction of the product and return to WalkMed LLC. Customers with questions were instructed to call 720-351-4966.
Quantity in commerce: 25,920 bags
Distribution: Nationwide Distribution
Product codes and lots: 20717525, 20717529, 20817502, 20817503, 20717509, 20717511, 20717512, 20717517, 20817500, 20717530

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0090-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0090-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-22	2017-11-13

Product code FRN

K870524Class IIAmbulatory Infusion Pump Drug ReservoirMed Fusion Systems, Inc. / cleared 1987-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)