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 2 Device Recall

  • 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 2 Device Recall see related information
Date Initiated by Firm April 29, 2021
Create Date June 21, 2021
Recall Status1 Terminated 3 on May 26, 2022
Recall Number Z-1910-2021
Recall Event ID 87958
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands -
Ultrasonic Transducer Cover

Item ID: A-AU- 0853NA
Code Information Lot Numbers: 1907E386 1911E049 1911E047 1911E261 1912E129 1912E128 2003E604 2003E633 2003E240 2003E932 2003E931 2005E439 2007E257 2010E215 2012E099 2012E506 2101E071 
Recalling Firm/
Manufacturer		 Exact Medical Manufacturing, Inc.
4917 William St Ste C
Lancaster NY 14086-3200
Manufacturer Reason
for Recall		 No 510k for the product to be used in a natural or surgical opening to the body
FDA Determined
Cause 2		 No Marketing Application
Action Exact Medical issued Correction Notification via email on 4/29/21. Letter states: Exact Medical Manufacturing Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not to be used in a natural or surgical opening to the body. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackers/relabelers establishments for further packaging and ethylene oxide sterilization. These are the boundaries and limitations of use for existing Probe/Transducer cover products in any existing stock from Exact Medical Manufacturing, Inc Further instructions will be given at a future date and we encourage you to reach out with any questions or concerns regarding this issue.
Quantity in Commerce 7920 units
Distribution US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
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.
-
-