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U.S. Department of Health and Human Services

Class 2 Device Recall FibriJet Endoscopic Catheter Introducer

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  Class 2 Device Recall FibriJet Endoscopic Catheter Introducer see related information
Date Initiated by Firm October 20, 2016
Create Date April 12, 2017
Recall Status1 Terminated 3 on July 23, 2019
Recall Number Z-1817-2017
Recall Event ID 75890
Product Classification Accessories, catheter - Product Code KGZ
Product Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Code Information Lot Number: 163010 Expiration date: June 2021
Recalling Firm/
Manufacturer		 Micromedics, Inc.
1270 Eagan Industrial Rd Ste 120
Saint Paul MN 55121-1385
For Additional Information Contact Customer Service
800-624-5662 Ext. 244
Manufacturer 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.
FDA Determined
Cause 2		 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 sharon.lynch@nordsonmedical.com 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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