Recall Z-2891-2011 ยท LRP Tray, Surgical
Deroyal Industries, Inc. Lafollette
DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA Lot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527 DeRoyal (R) Incision and Drainage Tray, RES 47-773, Rx Only, STERILE EO, Manufacturer: De
| Date | Jul 28, 2011 (initiated Apr 28, 2011) |
| Status | Terminated |
| Reason | Custom surgical kits contain recalled Triad PVP prep pads |
| Root cause | Other |
| Action | DeRoyal sent a Customer letter dated July 6, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to reference the attached spreadsheet to identify your accounts kits/trays and the corresponding lot numbers affected by this recall. Please complete and return the Acknowledgement Form by fax ( 865-362-3716) confirming you have been notified of this action. For further questions, please call ( 865) 362-2334. |
| Quantity | 11,856 kits/trays |
| Distribution | Nationwide Distribution--including the states of CA, FL,GA, HI, IL, IN, LA, MA, MO, MS, NY, PA, and RI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.