Recall Z-0114-04 ยท KKX Drape, Surgical, Antimicrobial
Medline Industries Inc
Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486
| Date | Nov 13, 2003 (initiated Oct 7, 2003) |
| Status | Terminated |
| Reason | The product, labeled as sterile, had not gone through the sterilization process at the time of shipment. |
| Root cause | Other |
| Action | Medline telephoned their sales represntatives on 10/7/03, instructing them to visit their accounts who received lot 03IA0532 and retrieve all cases of the lot distributed due to a quality issue. The accounts were informed that replacement product would be provided for the returned product. |
| Quantity | 44 cases |
| Distribution | Ohio, Iowa, Illinois, Wisconsin and Indiana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962205 | STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE Medline Industries, Inc., Nov 26, 1996 |