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Class 2 Device Recall FibriJet Endoscopic Catheter Introducer |
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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
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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
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For Additional Information Contact |
Customer Service 800-624-5662 Ext. 244
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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.
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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
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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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