Home / Recalls / Alto Development Corp / Z-2098-2019

Z-2098-2019 Class II Terminated

Recalled by Alto Development Corp — Wall Township, NJ

Recall Details

Product Type
Devices
Report Date
August 7, 2019
Initiation Date
June 21, 2019
Termination Date
May 13, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
351.5 Boxes

Product Description

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.

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.

Distribution Pattern

Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.

Code Information

Lots 0715A or later

Other recalls by Alto Development Corp

  • Z-0243-2020 Class II — A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture f (September 10, 2019)
  • Z-0242-2020 Class II — A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fix (September 10, 2019)
  • Z-0244-2020 Class II — A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fix (September 10, 2019)
  • Z-0245-2020 Class II — A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture f (September 10, 2019)
  • Z-0246-2020 Class II — A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fix (September 10, 2019)
  • Z-0813-2018 Class II — Surgical punch; sealed pouches packed in punch shelf box Intended for use by (October 23, 2017)