Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
Recall
- Recall Number
- Z-1625-2009
- Event Number
- 52189
- Firm
- Boston Scientific Corp
- FEI Number
- 1828132
- Product Code
- KNT
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 5, 2009
- Terminated
- October 13, 2010
- Address
- 780 Brookside Dr, Spencer, IN, 47460-1080
Description
Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile, Boston Scientific Corp., Natick, MA; Cat. no./REF 6647, inner pouch UPN M00566470 and outer carton UPN M00566471. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
Boston Scientific Corporation issued an "Urgent Medical Device Recall - Immediate Action Required" notice dated May 5, 2009 as follow-up to their "Recall of the Safety and Standard Push PEG Kits" dated December 30, 2008. The notice outlined the issue and Consignees were instructed to locate and return all affected product to the firm. In addition, the firm requests that users complete and return a Reply Verification Tracking Form via fax to 1-508-683-5578. For further questions, contact the Boston Scientific Corporation Field Action Team by phone at 1-508-683-4678.
Worldwide Distribution -- United States, India, Japan and Slovenia.
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