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
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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
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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.
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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 |
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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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510(K) Database | 510(K)s with Product Code = LDF
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