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U.S. Department of Health and Human Services

Class 2 Device Recall

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  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-1912-2021
Recall Event ID 87958
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band -
Ultrasonic Transducer Cover
Item ID: A-AU-10- 058N
Code Information Lot Numbers:  1912E127 2003E794 2002E132 2003E801 2004E024 2004E514 2009E127 2008E357 2009E467 2009E250 2011E108 2012E100 2012E104 
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 9680 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.
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