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U.S. Department of Health and Human Services

Class 2 Device Recall Reservoir Bag for Infusion Pump

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  Class 2 Device Recall Reservoir Bag for Infusion Pump see related information
Date Initiated by Firm September 27, 2017
Create Date November 13, 2017
Recall Status1 Open3, Classified
Recall Number Z-0090-2018
Recall Event ID 78302
510(K)Number K870524  
Product Classification Pump, infusion - Product Code FRN
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
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.
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

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = MEDFUSION SYSTEMS, INC.
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