Home / Recalls / Sterilmed Inc / Z-0213-2018

Z-0213-2018 Class I Terminated

Recalled by Sterilmed Inc — Minneapolis, MN

FDA device recall Z-0213-2018 was initiated by Sterilmed Inc on June 2, 2017 and is designated Class I. Reason for recall: Inadequate seal due to lack of adhesive glue The recall status is terminated (terminated July 29, 2019). Affected quantity: 112 devices.

Recall Details

Product Type
Devices
Report Date
January 3, 2018
Initiation Date
June 2, 2017
Termination Date
July 29, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112 devices

Product Description

St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Reason for Recall

Inadequate seal due to lack of adhesive glue

Distribution Pattern

US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.

Code Information

Model No. STJ408309, STJ408310, STJ408324. Exp. Date of 05/31/2018 or PRIOR. All Lots, known lots: 7344024, 7343120, 7343643, 7343797, 7348305, 7355750, 7348712, 7290257, 7354522, 7354523, 7350001, 7324499, 7343501, 7351203, 7255673, 7273483, 7343603, 7355439, 7355745, 7355754, 7355752, 7282741, 7315539, 7320863, 7343766, 7351038, 7330645, 7345143, 7323722, 7330603, 7342081, 7351724, 7352687, 7355130, 7355131, 7355137, 7377760, 7355135, 7375662, 7404300, 7404301, 7404316, 7404306, 7343395, 7355463, 7355714, 7355622, 7330666, 7355572, 7327999, 7355677, 7308337, 7343686, 7355680, 7251903, 7259400, 7322815, 7342069, 7355574, 7355676, 7355712, 7346336, 7355666, 7355661, 7355618, 7355571, 7354437, 7350573, 7331054, 7300290, 7350792, 7355679, 7355709, 7355713, 7355681, 7355675, 7355573, 7345129, 7343838, 7355678, 7355575, 7355620, 7355711, 7346820, 7355662, 7404299, 7404282, 7404294, 7404290, 7404310, 7404311, 7404318, 7404297, 7404287, 7342672, 7357129, 7241712, 7350942, 7272027, 7316930, 7345592, 7348169, 7388731, 7372138, 7386929, 7387147

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-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)
  • Z-0059-2015 Class II — Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, C (September 24, 2014)

FDA data resources