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Terminated

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

FDA Recall Z-1817-2017 · Posted None

Recalling FirmMicromedics, Inc.
Recall StatusTerminated
Product CodeKGZ
Date Initiated2016-10-20
Date Terminated2019-07-23
Product Quantity273 units

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.

Firm 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.

Root Cause

Employee error

Distribution Pattern

AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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