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U.S. Department of Health and Human Services

Class 3 Device Recall Portex Continuous Epidural Tray

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  Class 3 Device Recall Portex Continuous Epidural Tray see related information
Date Initiated by Firm July 15, 2009
Date Posted September 03, 2009
Recall Status1 Terminated 3 on September 14, 2012
Recall Number Z-2050-2009
Recall Event ID 52695
510(K)Number K062005  
Product Classification Anesthesia Conduction Catheter - Product Code BSO
Product Portex Continuous Epidural Tray, Reference 4037-20

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia.
Code Information Lot # 1579258 
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact
603-352-3812
Manufacturer Reason
for Recall		 Portex Continuous Epidural Tray was distributed with a 20G closed end, three eyed, nylon catheter without a stylet instead of the 20 G open end Teflon catheter with stylet specified on the label.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Smiths Medical notified consignees by an Urgent Device Recall letter dated July 15, 2009, to locate and quarantine the affected product, stop distribution, and complete and fax back the attached Distributor Reply Letter to Smiths Medical. Credit or replacement will be arranged as requested for the return of any affected product. All distributors will be required to return any affected product in stock. All of the distributors will be required to send their customer list to Smiths Medical who will notify their customers of this recall.
Quantity in Commerce 190 kits (19 cases)
Distribution Nationwide Distribution -- including states of New York, Texas, Ohio, Utah, Alabama, Arizona, Kentucky, & Wyoming.
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.
510(K) Database 510(K)s with Product Code = BSO and Original Applicant = SMITHS MEDICAL ASD, INC.
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