Home / Recalls / PEROUSE MEDICAL / Z-0876-2015

Z-0876-2015 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
24821 units

Product Description

Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures

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

All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407

Other recalls by PEROUSE MEDICAL

  • Z-1891-2017 Class II — DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SN (April 5, 2017)
  • Z-0877-2015 Class II — Synthes Inflation System (03.804.4135) Product Usage: Inflation system is u (October 6, 2014)
  • Z-2089-2014 Class II — Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular (May 10, 2012)