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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm September 09, 2004
Date Posted September 29, 2004
Recall Status1 Terminated 3 on May 16, 2005
Recall Number Z-1495-04
Recall Event ID 30045
510(K)Number k030365  
Product Classification Drape, Surgical - Product Code KKX
Product Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60'', 8 X 60'', Ref#9991-60, #9993-60
Code Information Lot: 932924  1330482  1407048  
Recalling Firm/
Manufacturer		 Deroyal Surgical -Rose Hill
100 Rose Hill Industrial Park
Rose Hill VA 24281
For Additional Information Contact Gracie Greenway
888-938-7828 Ext. 1025
Manufacturer Reason
for Recall		 Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
FDA Determined
Cause 2		 Other
Action The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.
Quantity in Commerce 3 cases
Distribution Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
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 = KKX and Original Applicant = DEROYAL INDUSTRIES, INC.
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