Recall Z-1730-2009 ยท MMP Cover, Barrier, Protective
GE Medical Systems, LLC
GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS 00-900493-03 COVER DISPOSABLE X-RAY TUBE 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) 00-900605
| Date | Aug 14, 2009 (initiated Aug 29, 2008) |
| Status | Terminated |
| Reason | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Consignees were sent 8/29/08 a GE Healthcare "Urgent Recall Notice" dated August 15, 2008. The letter was addressed to Director / Manager of Radiology and Director of Surgery. The letter described the problem and provided a list of products, solutions and requested the return of the attached fax forms. In the event of any questions or concerns, a service team should be contacted at 800-874-7378 option #8. |
| Quantity | 137,689 (123,373 US; 14,316 OUS) |
| Distribution | Worldwide Distribution -- USA, Canada, Australia, Bahamas, China, Hong Kong, Italy, Japan, Korea, Mexico, Malaysia, Singapore, and El Salvador. |
| 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 |