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).
Recall
- Recall Number
- Z-1709-2009
- Event Number
- 52561
- Firm
- GE Medical Systems, LLC
- FEI Number
- 2126677
- Product Code
- MMP
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- August 15, 2008
- Posted
- September 1, 2009
- Terminated
- May 15, 2012
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
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).
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.
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.
Nationwide Distribution -- AZ, CA, FL, MD, NY, OR, PA, SC and TX.
50 each