Z-1817-2017Class II

Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using...

Name: Z-1817-2017 Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using...
Creator: Micromedics, Inc.
Published: 2016-10-20
License: https://open.fda.gov/license/

Micromedics, Inc. / initiated 2016-10-20 / Terminated / root cause: manufacturing process

FDA source

Micromedics, Inc. began a recall of Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide on 2016-10-20. FDA classified it as Class II and gives the reason as "The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance". 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-1817-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-20
Posted: 2017-04-12
Terminated: 2019-07-23
Recalling firm: Micromedics, Inc.
Product: Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Product code: KGZ Accessories, Catheter
Reason for recall: The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: A Medical Device Recall Letter was sent to customers beginning 10/20/2016 via Federal Express in the US and via UPS ground in Israel. The letter identified the affected device and lot number, issue, asked for product to be discontinued from use, quarantine and notify Nordson Medical, via a response form. Response form can be faxed back at 888-504-0606, email to [email protected] or mailed to Nordson Medical, 1270 Eagan Industrial Road, Suite 120, St. Paul, MN 55121.
Quantity in commerce: 273 units
Distribution: AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel
Product codes and lots: Lot Number: 163010 Expiration date: June 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1817-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1817-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12

Product code KGZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)