Home / Recalls / CIVCO Medical Instruments Co., Inc. / Z-0563-2019

Z-0563-2019 Class II Terminated

Recalled by CIVCO Medical Instruments Co., Inc. — Coralville, IA

Recall Details

Product Type
Devices
Report Date
December 19, 2018
Initiation Date
November 2, 2018
Termination Date
November 20, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,375 boxes

Product Description

SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.

Reason for Recall

The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly.

Distribution Pattern

Foreign distribution was made to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.

Code Information

Boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, and all brackets in inventory that no longer have the product labeling.

Other recalls by CIVCO Medical Instruments Co., Inc.

  • Z-1892-2025 Class II — BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or cat (May 1, 2025)
  • Z-0398-2022 Class II — VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX (October 8, 2021)
  • Z-0396-2022 Class II — VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX (October 8, 2021)
  • Z-0395-2022 Class II — VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX (October 8, 2021)
  • Z-0397-2022 Class II — VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX (October 8, 2021)
  • Z-0574-2019 Class II — CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use wi (November 2, 2018)
  • Z-0572-2019 Class II — CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with s (November 2, 2018)
  • Z-0575-2019 Class II — CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use (November 2, 2018)
  • Z-0564-2019 Class II — CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use (November 2, 2018)
  • Z-0569-2019 Class II — CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable no (November 2, 2018)