Recall Z-0963-2012 ยท LRP Tray, Surgical
DeRoyal Industries Inc
Sterile surgical kits: DeRoyal SELECTIVE ARTERIOGRAM PACK, REF 89-7284.02 Lot Number: 26166359; DeRoyal UNIVERSAL PACK, REF 89-7237.01 Lot Number: 26013627; DeRoyal NEURO BASIC PACK, REF 89-7229.01 Lot number: 26013635; DeRoyal C-SECTION TRAY, REF 89-5256.06 Lot Number: 26185242; DeRoyal C V MINOR TRAY, REF 89-5277.02 Lot Number: 25793211; DeRoyal COMBINED EXTREMITY PACK, REF 89-6773.02
| Date | Feb 6, 2012 (initiated Jun 14, 2011) |
| Status | Terminated |
| Reason | Custom surgical kits contain recalled Kimberly Clark surgical drapes which were found to contain metal shavings in the folds of the drapes. |
| Root cause | Nonconforming Material/Component |
| Action | DeRoyal Industries Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL OF KIMBERLY-CLARK THREE-QUARTER DRAPE 79147" letter dated June 14, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify and quarantine all affected product. Further instructions by the firm asks customers to complete and return a Recall Response Spreadsheet via fax to 865-362-3744. Customers should contact their Deroyal Sales Representative for questions or assistance regarding this recall. |
| Quantity | 3881 kits |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.