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 FirmSeptember 09, 2004
Date PostedSeptember 29, 2004
Recall Status1 Terminated 3 on May 16, 2005
Recall NumberZ-1490-04
Recall Event ID 30045
510(K)NumberK030365 
Product Classification Drape, Surgical - Product Code KKX
ProductImpervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16
Code Information Lot # 1007298  1007335  1007360  1030228  1030244  1045526  1049113  1081519  1107441  1141972  1161316  1161332  1200979  1225252  1306538  1310369  1315021  1330597  1330600  1342811  1375681  1375808  1375816  1490540  1504008  1504032  1521713  1543630  1571438  1650988  1736028  1759511  1802072  1911543  1911615  2076658  2076738  2137810  2137828  2138062  2187067  2228121  2376204  2701345  765821  765855  804316  805431  805440  825580  825598  825635  825643  850507  900691  932991  933071  933097  933118  933151  950663  950680  950743  974585  974593  974665  
Recalling Firm/
Manufacturer		 Deroyal Surgical -Rose Hill
100 Rose Hill Industrial Park
Rose Hill VA 24281
For Additional Information ContactGracie 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
ActionThe 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 Commerce1971 cases
DistributionProduct was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
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 = KKX
-
-