Recall Z-0268-2007 ยท LRO General Surgery Tray
Medline Industries Inc
Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; Medline Industries, Inc., Mundelein, IL 60060-4486
| Date | Dec 14, 2006 (initiated Nov 21, 2006) |
| Status | Terminated |
| Reason | The product, labeled as sterile, had not gone through the sterilization process at the time of shipment. |
| Root cause | Other |
| Action | On 11/21/06, Medline telephoned the accounts who may have received the recalled lots, informing them that the skin scrub trays may not have gone through the full manufacturing cycle and are not sterile. They were requested to check their inventories for the two affected lots, removing any found from inventory and placing it on hold for return to Medline. The accounts were then sent a recall letter via fax on the same date, reiterating the telephone calls, and requesting the accounts to complete and fax back the attached response form, indicating amount of each lot placed on hold. Any questi |
| Quantity | 47 cases |
| Distribution | Minnesota, Illinois, Wisconsin and Indiana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914174 | STERILE DISPOSABLE WET SKIN SCRUB TRAY Medical Device Inspection Co., Inc., Feb 24, 1992 |