Recall Z-2228-2011 ยท LRP Tray, Surgical
Deroyal Industries, Inc. Lafollette
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.
| Date | May 20, 2011 (initiated Feb 7, 2011) |
| Status | Terminated |
| Reason | Custom surgical kits contained either one or more of the following possible contaminated recalled products: Triad lubricating jelly, alcohol prep pads, and alcohol swabs. |
| Root cause | 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 a |
| Quantity | 340,976 units total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.