Recall Z-1709-2009 ยท MMP Cover, Barrier, Protective
GE Medical Systems, LLC
Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper).
| Date | Sep 1, 2009 (initiated Aug 15, 2008) |
| Status | Terminated |
| Reason | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported. |
| Root cause | Packaging process control |
| Action | GE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response form. |
| Quantity | 50 each |
| Distribution | Nationwide Distribution -- AZ, CA, FL, MD, NY, OR, PA, SC and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Apr 17, 2002 |
| K782155 | GENERAL EQUIPMENT COVER Contour Fabricators, Inc., Jan 17, 1979 |
| K820692 | BANDBAG, WRAP, STERILE Contour Fabricators, Inc., May 3, 1982 |
| K970185 | STERILE DISPOSABLE EQUIPMENT MAGNET COVER Contour Fabricators, Inc., Apr 10, 1997 |
| K993687 | UROVIEW 2800 Ge Dec Medical Systems, Dec 21, 1999 |