GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERI
FDA device recall Z-1730-2009 · posted 2009-08-14 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- MMP
- Quantity affected
- 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.
- Date initiated
- 2008-08-29
- Date posted
- 2009-08-14
- Date terminated
- 2012-05-15
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM (K021049) | Ge Oec Medical Systems | 2002-04-17 |
| UROVIEW 2800 (K993687) | Ge Dec Medical Systems | 1999-12-21 |
| STERILE DISPOSABLE EQUIPMENT MAGNET COVER (K970185) | Contour Fabricators, Inc. | 1997-04-10 |
| BANDBAG, WRAP, STERILE (K820692) | Contour Fabricators, Inc. | 1982-05-03 |
| GENERAL EQUIPMENT COVER (K782155) | Contour Fabricators, Inc. | 1979-01-17 |