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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Aquasonic 100 Ultrasound Transmission Gel

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  Class 2 Device Recall Sterile Aquasonic 100 Ultrasound Transmission Gel see related information
Date Initiated by Firm April 13, 2017
Create Date May 09, 2018
Recall Status1 Terminated 3 on October 26, 2020
Recall Number Z-1777-2018
Recall Event ID 79910
510(K)Number K802146  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Code Information Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006
Recalling Firm/
Manufacturer		 Parker Laboratories, Inc.
286 Eldridge Rd
Fairfield NJ 07004-2509
For Additional Information Contact
973-276-9500
Manufacturer Reason
for Recall		 There is a potential for the gel packets to have leaks in the packet seal.
FDA Determined
Cause 2		 Process control
Action Notification letters distributed 4/13/17 instructed customers to perform the following: We request that you quarantine any affected product in your inventory and contact Parker to discuss options for disposition of the recalled products in question. Should you identify any customers to whom the affected product may have already been distributed, we would be happy to provide you with a customer letter that can be transcribed onto your own company letterhead for the purposes of notifying them of this quality issue. Please completed the attached response form as soon as possible and return it to us at the email or fax number listed on the form, so that further arrangements can be made.
Quantity in Commerce 3275 cases/1310000 packets
Distribution The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.
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.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = PARKER LABORATORIES, INC.
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