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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal (R) AMNIOCENTESIS TRAY

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  Class 2 Device Recall DeRoyal (R) AMNIOCENTESIS TRAY see related information
Date Initiated by Firm February 07, 2011
Date Posted May 20, 2011
Recall Status1 Terminated 3 on August 06, 2014
Recall Number Z-2228-2011
Recall Event ID 58675
Product Classification Tray, surgical - Product Code LRP
Product Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal (R) AMNIOCENTESIS TRAY, LINK DREW LACO HOSP, REF 50-11656.02, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA.
Code Information REF 50-11656.02: Lot Number 19321517
Recalling Firm/
Manufacturer		 Deroyal Industries, Inc. Lafollette
1501 East Central Ave
La Follette TN 37766-2892
For Additional Information Contact Tracy Edmundson
865-362-2334
Manufacturer Reason
for Recall		 Custom surgical kits contained either one or more of the following possible contaminated recalled products: Triad lubricating jelly, alcohol prep pads, and alcohol swabs.
FDA Determined
Cause 2		 Other
Action DeRoyal notified their consignees by letter with the subject line "Re: DeRoyal Recall of Triad Medical Lubricating Jelly, Alcohol Prep Pads and Alcohol Swabs" on 02/07/2011 that kits in their possession contained recalled Triad products that were possibly contaminated. Customers were to use the attached spreadsheet to identify and quarantine the affected product. The spreadsheet should have been completed even if there was no affected product. The form should have been faxed back to 865-362-3716 or emailed to recalls@deroyal.com. Customers' DeRoyal Sales Representative would re-label the affected product in order to prevent further use. The DeRoyal Sales Representatives are also providing in-service training on effectuating this recall, including the importance of identifying, retrieving and discarding the recalled products as well as the documentation necessary to account for these products. Distributors were directed to recall down to the retail level. If there are questions or if further assistance is needed, customers can contact their DeRoyal Sales Representative or customer support department at 1-800-251-9864.
Quantity in Commerce 340,976 units total
Distribution Nationwide Distribution
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.
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