Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Portex

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Portex see related information
Date Initiated by Firm November 17, 2005
Date Posted November 30, 2005
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0249-06
Recall Event ID 34046
Product Classification Anesthesia Conduction Kit - Product Code CAZ
Product 4954-17 Portex¿ Epidural Mini-pack
Code Information Lot Numbers: K167341, K184428, K197145, K209523, K222123, K502514, K512986, K517133, K523565, K525700, K529957, K554390, K558495, K573614, K630925, K633623, K656459, K673351, K688226, K704809
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact Timothy J. Talcott
603-352-3812 Ext. 2457
Manufacturer Reason
for Recall		 Tray may contain holes compromising the sterility of the device
FDA Determined
Cause 2		 Other
Action Smiths Medical ASD notffied accounts by letter via UPS or Fedex on November 17, 2005. Customers and dealers are directed to fax back the attached Reply Letter to Smiths Medical, Keene even if the customer/dealer no longer has affected products in inventory
Distribution Nationwide
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.
-
-