Home / Recalls / Civco Medical Instruments Inc / Z-0803-2014

Z-0803-2014 Class II Terminated

Recalled by Civco Medical Instruments Inc — Kalona, IA

Recall Details

Product Type
Devices
Report Date
January 29, 2014
Initiation Date
October 25, 2013
Termination Date
February 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 belly board

Product Description

Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

Reason for Recall

Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.

Distribution Pattern

Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.

Code Information

Lot#'s: M551490 and M550150

Other recalls by Civco Medical Instruments Inc

  • Z-1400-2015 Class II — CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopic (February 26, 2015)
  • Z-2558-2014 Class II — CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/ (August 1, 2014)
  • Z-0802-2014 Class II — Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, R (October 25, 2013)
  • Z-1953-2012 Class II — CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnet (May 7, 2012)
  • Z-1956-2012 Class II — CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose drive (May 7, 2012)
  • Z-1955-2012 Class II — CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnet (May 7, 2012)
  • Z-1954-2012 Class II — CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnet (May 7, 2012)
  • Z-1952-2012 Class II — CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose drive (May 7, 2012)