Home / Recalls / PEROUSE MEDICAL / Z-0877-2015

Z-0877-2015 Class II Terminated

Recalled by PEROUSE MEDICAL — Ivry Le Temple, N/A

Recall Details

Product Type
Devices
Report Date
January 7, 2015
Initiation Date
October 6, 2014
Termination Date
March 24, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2184 units

Product Description

Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter

Reason for Recall

Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure

Distribution Pattern

US Nationwide Distribution in the states of AZ and CO.

Code Information

Batch numbers: 4041354/4062650/4072586

Other recalls by PEROUSE MEDICAL

  • Z-1891-2017 Class II — DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SN (April 5, 2017)
  • Z-0876-2015 Class II — Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device inte (October 6, 2014)
  • Z-2089-2014 Class II — Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular (May 10, 2012)