FDAClass IIApril 19, 2017

Nordson Micromedics FibriJet Endoscopic Catheter recall: Sterility Concern

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

Why was Nordson Micromedics FibriJet Endoscopic Catheter recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 163010 Expiration date: June 2021

Product
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Recalling firm
Micromedics, Inc.
Quantity
273 units
Distribution
AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel
Recall date
April 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls