Recall Z-1137-03 ยท KKX Drape, Surgical, Antimicrobial
Molnlycke Health Care Inc
Barrier Hip Sheet with Side Pockets
| Date | Aug 14, 2003 (initiated Jul 14, 2003) |
| Status | Terminated |
| Reason | pouch may tear which could result in contamination of sterile field |
| Root cause | Other |
| Action | The recalling firm issued recall letters dated 7/9/03 to their direct accounts informing them of the problem/reason for recall, the need to return the product and to contact their customers regarding the recall. |
| Quantity | 2714 units |
| Distribution | The products were shipped to distributors, hospitals, and sales representatives nationwide. The product was also shipped to dealers in Australia, New Zealand, Canada, and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780282 | BARRIER HIP PACK W/ FABRIC 450 Surgikos, Inc., Feb 28, 1978 |