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U.S. Department of Health and Human Services

Class 1 Device Recall Multipe (see code info)

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  Class 1 Device Recall Multipe (see code info) see related information
Date Initiated by Firm August 04, 2021
Create Date September 17, 2021
Recall Status1 Open3, Classified
Recall Number Z-2469-2021
Recall Event ID 88483
510(K)Number K955246  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product Ultrasound Gel labeled under the following brand names:
MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel
Code Information Item Numbers: 1) 001205 (LiquaSonic Ultrasound Gel, 8.5oz) 2) 001222 (LiquaSonic Ultrasound Gel, 5L) 3) 30GB (EcoGel 100, 250ml, 12/cs) 4) 5005L4 (MAC EcoGel 5L, 4/cs) 5) 500812 (MAC EcoGel, 250ml, 12/cs) 6) M50008 (MediChoice Empty 8oz bottle) 7) M5005L4 (MediChoice USG 5L, 4/cs) 8) M500812 (MediChoice, 250ml, 12/cs) 9) 50TB (EcoGel High V TENS, 250ml) 10) 40JBB (EcoGel Multipurpose Ultrasound Gel, 250ml, 8oz, 12/cs) 11) 40JBHV-24 (EcoGel Blue High Velocity Ultrasound Gel, 250ml, 24/cs) 12) 40JMC (EcoGel 200 MultiPurpose Clear Ultrasound Gel 4-5ml Cubes with 4 dispenser bottles, 5L, 4/cs) 13) 20400 (MAC Ultrasound Gel Packet - Multipurpose) All lots shipped between 08/2018 and 08/2021.
Recalling Firm/
Manufacturer
Mac Medical Supply Co Inc
9200 Calumet Ave Ste NW08
Munster IN 46321-0047
For Additional Information Contact Mr. William O. Maddocks
773-650-9400
Manufacturer Reason
for Recall
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
FDA Determined
Cause 2
Process control
Action Email notification was made to consignees on 08/25-26/2021. The recall is extended to all customers which includes distributors, medical facilities, retail and users. Customers are asked to identify their impacted customers and forward the recall notification to those customers that have received impacted product. Customers are asked to destroy all affected product at their facility and return the recall response form. Customers are advised that destruction of product should render it unusable. Customers must contact MAC Medical Supply to confirm receipt of the notice and that they are proceeding with the recall via email, recall@macmed.com. To contact MAC Medical Supply directly with questions, call 800-523-8337, ask for recall coordinator.
Quantity in Commerce 100,114 units
Distribution United States 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 = ITX and Original Applicant = ECO-MED PHARMACEUTICALS, INC.
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