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.
This recall has been terminated (originally issued January 28, 2009).
- Company
- Boston Scientific Corp
- Recall Initiated
- December 30, 2008
- Posted
- January 28, 2009
- Terminated
- October 30, 2009
- Recall Number
- Z-0911-2009
- Quantity
- 2460 of all products
- Firm Location
- Spencer, IN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide.
Lot / Code Info
Inner pouch (UPN M00566470) lots 12004380, 12017735, 12039127, 12068485, 12074073, 1209443, 12115001, 12127100 and 12159831 Packaged in outer cartons (UPN M00566471) with lot numbers of 12069493, 12069494, 12112331, 12123598 and 12145424.
Root Cause
Other
Action Taken
Consignees were notified by "Urgent Medical Device Recall" letter dated 12/30/08. The letter described the problem with the product, instructed customers to determine whether they store these products in the outer carton or the inner pouch at their facility, to locate all affected products, and to return them to the firm. For additional information, contact Boston Scientific Corporation at 1-508-683-4678.