Home / Recalls / Civco Medical Instruments Co. Inc. / Z-1892-2025

Z-1892-2025 Class II Ongoing

Recalled by Civco Medical Instruments Co. Inc. — Kalona, IA

Recall Details

Product Type
Devices
Report Date
June 11, 2025
Initiation Date
May 1, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
506 boxes

Product Description

BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

Reason for Recall

During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

Distribution Pattern

OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark

Code Information

UDI-DI: 00841436120050; Lot Numbers: A174424, A176855, A177208, A182744, A184023, A185336, A185337, A186904, A189734, A190489, A193623, A194755, A198716, A198795, A199940, A200430, A202208, A203169, A203201, A203520, A205457, A207901, A208740, A211619, A212291, A213027, A215531, A216885, A217412, A220102, A221365, A221925, A225145, A226800, A228446, A228778, A229092, A229898, A230045, A230054, A230549, A230581, A231101, A231810, A232903, A233075, A233535, A236538, A238767, A239339, A239355, A240873, A240931, A241445, A242018, A242161, A243263, A243264, A245342, A245527, A246173, A248520, A248572, A250325, A252513, A252842, A254080, A254081, A254900, A254955, A255332, A257534, A258150, A258926, A260607

Other recalls by Civco Medical Instruments Co. Inc.

  • Z-0396-2022 Class II — VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX (October 8, 2021)
  • Z-0398-2022 Class II — VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX (October 8, 2021)
  • Z-0397-2022 Class II — VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX (October 8, 2021)
  • Z-0395-2022 Class II — VirtuTRAX Instrument Navigator, Sensor with 14 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-0566-2019 Class II — SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non (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-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)
  • Z-0565-2019 Class II — CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket f (November 2, 2018)