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Class 2 Device Recall Reservoir Bag for Infusion Pump |
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Date Initiated by Firm |
September 27, 2017 |
Create Date |
November 13, 2017 |
Recall Status1 |
Terminated 3 on December 27, 2017 |
Recall Number |
Z-0090-2018 |
Recall Event ID |
78302 |
510(K)Number |
K870524
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Product Classification |
Pump, infusion - Product Code FRN
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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. |
Code Information |
20717525, 20717529, 20817502, 20817503, 20717509, 20717511, 20717512, 20717517, 20817500, 20717530 |
Recalling Firm/ Manufacturer |
WalkMed, LLC 6555 S Kenton St Ste 304 Englewood CO 80111-6838
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Manufacturer 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.
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FDA Determined Cause 2 |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FRN and Original Applicant = MEDFUSION SYSTEMS, INC.
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