Home / Recalls / STERILMED, INC. / Z-0059-2015

Z-0059-2015 Class II Terminated

Recalled by STERILMED, INC. — Maple Grove, MN

Recall Details

Product Type
Devices
Report Date
October 15, 2014
Initiation Date
September 24, 2014
Termination Date
August 11, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22

Product Description

Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.

Reason for Recall

Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne

Distribution Pattern

US Distribution including the states of WA and CA.

Code Information

Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577

Other recalls by STERILMED, INC.

  • Z-0574-2026 Class II — Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHET (October 8, 2025)
  • Z-0573-2026 Class II — Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH S (October 8, 2025)
  • Z-0090-2019 Class II — Reprocessed Agilis Steerable Introducer: indicated for introducing various card (September 17, 2018)
  • Z-0213-2018 Class I — St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 2 (June 2, 2017)
  • Z-2669-2017 Class II — Electrophysiology catheter cables are designed as electrode cables with a multi (May 8, 2017)
  • Z-1846-2016 Class II — Reprocessed Microline Scissor Tips intended to be used with a reusable hand piec (April 26, 2016)
  • Z-0404-2016 Class II — Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed (November 13, 2015)
  • Z-2819-2015 Class II — Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (August 24, 2015)