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 Portexsee related information
Date Initiated by FirmNovember 17, 2005
Date PostedNovember 30, 2005
Recall Status1 Terminated 3 on May 08, 2012
Recall NumberZ-0243-06
Recall Event ID 34046
510(K)NumberK965017 
Product Classification Anesthesia Conduction Kit - Product Code CAZ
Product4903 Glass L.O.R. Syringe
Code Information Lot Numbers: 102517, K154089, K211495, K222113, K512485, K522220, K538711, K559480, K573554, K618300, K643592, K669735, K686834, K700785
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information ContactTimothy 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
ActionSmiths 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
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CAZ
-
-