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

  • 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 Recallsee related information
Date Initiated by FirmJune 09, 2005
Date PostedJune 28, 2005
Recall Status1 Terminated 3 on September 21, 2005
Recall NumberZ-0941-05
Recall Event ID 32422
510(K)NumberK920579 
Product Classification Tubes, Gastrointestinal (And Accessories) - Product Code KNT
ProductLow Profile Gatrostomy - Contents include: Passport & Obturator * Disposable Single Use Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.
Code Information Lot Number: WR1827952, Labeled Reorder Number LPG-20-2.4-A and Lot Number W1834577, Labeled Reorder Number PASS-20-3.4-A
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information ContactSharon Miles
336-744-0157
Manufacturer Reason
for Recall		The reorder number listed on the product label is inaccurate.
FDA Determined
Cause 2		Other
ActionConsignees were notified by email/fax on 06/17/2005.
Quantity in Commerce6 units
DistributionBrazil, Japan & Hong Kong
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 = KNT
-
-