Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0090-2018 · Posted None

Recalling FirmWalkMed, LLC
Recall StatusTerminated
Product CodeFRN
Date Initiated2017-09-27
Date Terminated2017-12-27
Product Quantity25,920 bags

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K870524AMBULATORY INFUSION PUMP DRUG RESERVOIRMed Fusion Systems, Inc. · 1987-05-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑