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U.S. Department of Health and Human Services

Class 1 Device Recall Alaris Medley LVP Frame Membrane

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  Class 1 Device Recall Alaris Medley LVP Frame Membrane see related information
Date Initiated by Firm June 03, 2015
Date Posted August 20, 2015
Recall Status1 Terminated 3 on March 07, 2017
Recall Number Z-2371-2015
Recall Event ID 71543
Product Classification Pump, infusion - Product Code FRN
Product Alaris Medley LVP Frame Membrane.

Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
Code Information P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000.
Recalling Firm/
Manufacturer		 Elite Biomedical Solutions LLC
5150 Fordon Ct
Cincinnati OH 45244-5021
For Additional Information Contact Mr. Jeff D Diesel
855-291-6701
Manufacturer Reason
for Recall		 Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
FDA Determined
Cause 2		 Other
Action Elite Biomedical Solutions, sent a "Product Advisory Notices" letter dated May 21, 2015 to their customers. On June 3, 2015 the firm sent an Urgent Medical Device Recall letter to their customers. The letter identified the affected product , problem and actions to be taken. And on June 12, 2015 a press release was issued via ECRI (Emergency Care Research Institute) to all hospitals in the US. The notification letter requested customers to: 1) inspect and quarantine affected products, 2) identify your customers and notify them at once of this product recall, and 3) complete and return the enclosed response forms. For any questions, call Elite Biomedical Solutions, LLC, Quality Manager, at 1-855-291-6701.
Quantity in Commerce 609 pieces
Distribution Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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