Z-0090-2019Class II

Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the...

Name: Z-0090-2019 Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the...
Creator: Sterilmed, Inc.
Published: 2018-09-17
License: https://open.fda.gov/license/

Sterilmed Inc / initiated 2018-09-17 / Terminated / root cause: manufacturing process

FDA source

Sterilmed, Inc. began a recall of Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm... on 2018-09-17. FDA classified it as Class II and gives the reason as "Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing". 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-0090-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-17
Posted: 2018-10-09
Terminated: 2020-08-04
Recalling firm: Sterilmed Inc
Product: Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324
Product code: PNH
Reason for recall: Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Sterilmed notified customers on about 09/17/2018, via URGENT MEDICAL DEVICE RECALL letter sent via UPS next day. Instructions included examine inventory for affected devices, remove and return affected devices to Stericycle (3rd party processor), provide recall information to appropriate personnel at the facility, and complete and return the Business Reply Form to Stericycle. For questions, contact Sterilmed's Customer Care Team at (888) 541-0078, Monday through Friday from 7:00 AM to 5:00 PM CST.
Quantity in commerce: 218 units
Distribution: U.S. Nationwide distribution in the states of CA, CO, MN, and WA.
Product codes and lots: All lots with expiration dates prior to 2019-06-08 of the following: (a) Product Code STJ408309, GTIN 10888551044912 (b) Product Code STJ408310, GTIN 10888551044929 (c) Product Code STJ408324, GTIN 10888551044950

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0090-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0090-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-09

Product code PNH

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)