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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-1493-04
Recall Event ID 30045
510(K)Number k030365  
Product Classification Drape, Surgical - Product Code KKX
Product Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48''
Code Information Lot: 1007212 1030172  1030181  1142043  1225324  1225332  1225341  1225359  1306298  1330669  1330677  1341190  1375832  1375841  1375867  1375875  1407072  1431304  1521772  1543672  1543681  1627016  1634152  1678542  1678606  1736079  1736087  1736095  1736108  1736116  1800384  1800608  1876426  1911375  1911421  2055689  2075217  2136454  2136471  2268684  2375877  728683  783421  805360  805378  805482  825555  900762  900797  900800  974681  974729  
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 709 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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