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 3 Device Recall

  • 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 3 Device Recall see related information
Date Initiated by Firm May 26, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 14, 2004
Recall Number Z-1003-04
Recall Event ID 29196
510(K)Number K874393  
Product Classification Tube, Feeding - Product Code FPD
Product Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable ¿ Single Use Only, Rx Only***COOK¿ Wilson ¿ Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Code Information Reorder/Catalog Number: NJFT-1-ML, Lot #1803299, Expiration Date: 09-2008
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Jessica Hughes
800-245-4707
Manufacturer Reason
for Recall		 The nasal transfer tube may be missing from the package of the affected lot.
FDA Determined
Cause 2		 Other
Action For the Domestic account, a recall letter was hand delivered by a Wilson-Cook representative on 5/26/2004. A letter was delivered via fax to International Distributors on 5/26/2004.
Quantity in Commerce 20 units
Distribution NC, Ireland & Poland
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 = FPD and Original Applicant = WILSON-COOK MEDICAL, INC.
-
-