Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall EcoMed

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall EcoMedsee related information
Date Initiated by FirmAugust 12, 2021
Create DateSeptember 22, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2480-2021
Recall Event ID 88584
510(K)NumberK955246 K961757 K962840 
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
ProductEcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.
Code Information 1) Ecogel 100 Imaging Gel, 250 mL bottle, Print Media Item Number 3541420 (12 each/pack; 72 each/case)  2) Ecogel 100 Imaging Gel, Set: 1 gal jug with 250mL dispenser, Print Media Item Number 3874672 (1 each/pack; 4 each/case)  3) Ecogel 200 Multipurpose Gel BLUE, 250mL bottle, Print Media Item Number 3113545 (12 each/pack, 72 each/case)   4) Ecogel 200 Multipurpose Gel BLUE, Set: 5L jug with 250mL dispenser, Print Media Item Number 1000033 (1 each/pack, 4 each/case)   5) Ecogel 200 Multipurpose Gel CLEAR, 250mL bottle, Print Media Item Number 3158655 (12 each/pack, 72 each/case)   6) Ecogel 200 Multipurpose Gel CLEAR, Set: 5L jug with 250mL dispenser, Print Media Item Number 7565432 (1 each/pack, 4 each/case)  7) Ecolotion Transmission Lotion, Set: 1 gal jug with 250mL dispenser, Print Media Item Number 6115004 (1 each/pack, 4 each/case)
Recalling Firm/
Manufacturer		 AMTEC SALES Inc
1594 Nw 159th St
Miami FL 33169-5635
For Additional Information ContactMario Grandela
305-884-0700
Manufacturer Reason
for Recall		Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
FDA Determined
Cause 2		Process control
ActionThe firm, Amtec/Print Media, issued a "URGENT: MEDICAL DEVICE RECALL - EXPANSION" notification letter to all impacted customers. This letter will be sent via email and includes a form that each customer is required to complete to indicate the recall information has been received and understood. The customers were also requested to do the following: 1. Please identify, quarantine, and destroy the product at your location; and provide a signed affidavit acknowledging its destruction. Please return this information via email to service@printmedia-inc.com or contact us for other return methods. 2. Forward this notice to any accounts to whom you have further distributed the product. 3. Please use the following link to verify your receipt and understanding of the attached MEDICAL DEVICE RECALL  EXPANSION notice/instructions, and provide quantity of products on hand. Please respond even if you do not have any affected product on hand, since this is our only way of ensuring that all customers have been adequately notified. https://lp.constantcontactpages.com/sv/jjwlFMb/urgentrecallnotice Customers must contact Print Media to confirm receipt of this notice and that they are proceeding with the recall via email, service@printmedia-inc.com, to contact Print Media directly with questions, call (800) 994-3318, or (305) 884-0700.
Quantity in Commerce34,586 each
DistributionWorldwide Distribution to US (nationwide) states of - FL, TX, OH, MD, PA, WA, CO, PR, VA, KY, OK, and CA; and OUS (international) to countries of - Honduras, Dominican Republic, El Salvador, Guatemala, Panama, and Costa Rica.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = ITX
-
-