Recall Z-2098-2019 ยท LDF Electrode, Pacemaker, Temporary
Alto Development Corp
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.
| Date | Jun 21, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 351.5 Boxes |
| Distribution | Distribution US Nationwide, Czech Republic, Italy, Israel, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K803086 | MYOWIRE-ATEMPORARY CARDIAC PACING WIRE Craig & Craig, Inc., Jul 1, 1981 |