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U.S. Department of Health and Human Services

Class 3 Device Recall SavaryGilliard Dilator

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  Class 3 Device Recall SavaryGilliard Dilator see related information
Date Initiated by Firm January 05, 2006
Date Posted January 25, 2006
Recall Status1 Terminated 3 on April 04, 2006
Recall Number Z-0441-06
Recall Event ID 34326
510(K)Number K851955  
Product Classification Dilator, Esophageal - Product Code KNQ
Product SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable
Code Information Lot W2048624
Recalling Firm/
Manufacturer		 Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Sharon Miles
336-744-0157 Ext. 6325
Manufacturer Reason
for Recall		 The dilator size does not match the label on the product and product packaging.
FDA Determined
Cause 2		 Other
Action A recall letter was issued to the consignees on 1/5/06 requesting return of the product. The letter also requested a sub-recall if the product had been further distributed.
Distribution Canada and Australia
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 = KNQ and Original Applicant = WILSON-COOK MEDICAL, INC.
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