Home / Recalls / Civco Medical Instruments Inc / Z-1400-2015

Z-1400-2015 Class II Terminated

Recalled by Civco Medical Instruments Inc — Kalona, IA

Recall Details

Product Type
Devices
Report Date
April 15, 2015
Initiation Date
February 26, 2015
Termination Date
February 28, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120 pouches

Product Description

CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.

Reason for Recall

Leaks were detected in the recalled lot which may compromise the sterility of the product.

Distribution Pattern

Distributed to the states of CA, IL, MA, MI, MO, and WI.

Code Information

Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01

Other recalls by Civco Medical Instruments Inc

  • Z-2558-2014 Class II — CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/ (August 1, 2014)
  • Z-0803-2014 Class II — Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion (October 25, 2013)
  • 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-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)
  • Z-1955-2012 Class II — CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnet (May 7, 2012)