Z-0213-2018Class I

St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID...

Name: Z-0213-2018 St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID...
Creator: Sterilmed Inc
Published: 2017-06-02
License: https://open.fda.gov/license/

Sterilmed Inc / initiated 2017-06-02 / Terminated / root cause: manufacturing process

FDA source

Sterilmed Inc began a recall of 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... on 2017-06-02. FDA classified it as Class I and gives the reason as "Inadequate seal due to lack of adhesive glue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0213-2018
Classification: Class I
Status: Terminated
Initiated: 2017-06-02
Posted: 2017-12-29
Terminated: 2019-07-29
Recalling firm: Sterilmed Inc
Product: 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.
Product code: DYB Introducer, Catheter
Reason for recall: Inadequate seal due to lack of adhesive glue
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Sterilmed sent an Urgent Medical Device Recall letter dated June 12, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory to determine if affected products are on hand, complete and return the Business Reply Form, share information with appropriate staff in facility, attach copy of this notification to quarantined product, and return affected product to Sterilmed. For questions contact Sterilmed's Customer Care Team at 888-541-0078.
Quantity in commerce: 112 devices
Distribution: US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0213-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0213-2018	Class I	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-28

Product code DYB

K152090Class IIReprocessed Steerable IntroducerSterilmed, Inc. / cleared 2016-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)