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 Brodmerkel Colon Decompression Set

  • 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 Brodmerkel Colon Decompression Setsee related information
Date Initiated by FirmOctober 08, 2003
Date PostedOctober 22, 2003
Recall Status1 Terminated 3 on November 10, 2004
Recall NumberZ-0048-04
Recall Event ID 27449
510(K)NumberK900035 
Product Classification Tube, Double Lumen For Intestinal Decompression And/Or Intubation - Product Code FEG
ProductBrodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035''/480 cm. Disposable Single use only, Rx Only. Cook, Wilson-Cook Medicl GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Code Information Catalog # CDSB-10, Lot #1589467
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc
4900 Bethania Station Rd
& 5951 Grassy Creek Blvd.
Winston-Salem NC 27105
For Additional Information ContactJessica Hughes
336-744-0157
Manufacturer Reason
for Recall		Product may be packaged with an incorrect instructions for use (IFU) booklet.
FDA Determined
Cause 2		Other
ActionRecall notification was sent via email to Wilson-Cook, sales representatives on 10/08/2003 for personal delivery to the affected accounts. Consignees were advised to quarantine and return all affected product via Federal Express (using Wilson-Cook Medical account) to the recalling firm. A verification form was included at the bottom portion of the notice to be returned with the affected product or faxed to Wilson-Cook. Replacement product or account credit will be provided upon receipt of any affected devices.
Quantity in Commerce9 pieces
DistributionThe product was distributed to Hospitals located in CA, NC, PA, and WI.
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 = FEG
-
-