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U.S. Department of Health and Human Services

Class 2 Device Recall A&E Medical Corp. UltraFlex

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  Class 2 Device Recall A&E Medical Corp. UltraFlex see related information
Date Initiated by Firm June 21, 2019
Create Date July 29, 2019
Recall Status1 Terminated 3 on May 13, 2020
Recall Number Z-2098-2019
Recall Event ID 83285
510(K)Number K803086  
Product Classification Electrode, pacemaker, temporary - Product Code LDF
Product A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)-
Temporary Pacing Electrode as follows:
021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0)
021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0)
021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0)
Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.
Code Information Lots 0715A or later
Recalling Firm/
Manufacturer		 Alto Development Corp
5206 Asbury Rd
Wall Township NJ 07727-3609
Manufacturer Reason
for Recall		 Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
FDA Determined
Cause 2		 Labeling Change Control
Action A&E Medical Corp issued on June 21, 2019 a Product Notice sent to customers who received M-21 pacing wires with Revision IFU advising customer of the change in instructions and providing a copy of the updated IFU for inclusion into any remaining inventory. Customers to confirm receipt of the notification and the results of inventory review by completing the attached Acknowledgement Form and emailing it to the address indicated on the form. Questions regarding this notification, please contact your A&E Medical Sales Representative or A&E Customer Service (800-323-4035
Quantity in Commerce 351.5 Boxes
Distribution Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.
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 = LDF and Original Applicant = CRAIG & CRAIG, INC.
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