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U.S. Department of Health and Human Services

Class 2 Device Recall Parker

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  Class 2 Device Recall Parker see related information
Date Initiated by Firm August 06, 2014
Date Posted October 29, 2014
Recall Status1 Terminated 3 on April 29, 2015
Recall Number Z-0145-2015
Recall Event ID 69224
510(K)Number K953673  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel

Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
Code Information Lot #D424, Part Number PM-038-0224E and BA-046-3801D 4/27/10
Recalling Firm/
Manufacturer		 Parker Laboratories, Inc.
286 Eldridge Road
Fairfield NJ 07004-2509
For Additional Information Contact Ms. Kathleen Tirch
973-276-9500 Ext. 7142
Manufacturer Reason
for Recall		 Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Parker Laboratories Inc. sent an "Urgent Medical Device Product Recall" Letter/Response Form via Fedex to their customers. The letter indentified the affected product, problem and actions to be taken. For questions contact Parker Laboratories Quality Assurance at 973-276-9500, ext. 7142.
Quantity in Commerce 367 boxes
Distribution Worldwide Distribution: US (Nationwide) and country of: Canada.
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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