Home / Recalls / Civco Medical Instruments Inc / Z-2558-2014

Z-2558-2014 Class II Terminated

Recalled by Civco Medical Instruments Inc — Kalona, IA

Recall Details

Product Type
Devices
Report Date
September 3, 2014
Initiation Date
August 1, 2014
Termination Date
January 28, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
52 kits

Product Description

CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.

Reason for Recall

A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.

Distribution Pattern

Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.

Code Information

Lot numbers: M431760, M431710, M426580, M430200, M423010

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-0802-2014 Class II — Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, R (October 25, 2013)
  • Z-0803-2014 Class II — Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion (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-1952-2012 Class II — CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose drive (May 7, 2012)
  • Z-1954-2012 Class II — CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnet (May 7, 2012)
  • Z-1955-2012 Class II — CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnet (May 7, 2012)