Important Safety Alerts

Medical device manufacturer, Boston Scientific, has issued a field safety notice (FSN) concerning its OffRoad Re-Entry Catheter System, with the following details:

• Material no.: H74939202070540
• Catalog no.: 39202-100540
• Lot no.: 16949014 (Expiration date on outer carton: May 2017); 16805826 (Expiration date on outer carton: March 2017); 16514008 (Expiration date on outer carton: November 2016); 16514006 (Expiration date on outer carton: November 2016); 16548224 (Expiration date on outer carton: October 2016)

The OffRoad Re-Entry Catheter System consists of two components, which are contained in an outer carton: the OffRoad Positioning Balloon Catheter and the OffRoad Micro-Catheter Lancet. The manufacturer has become aware that the outer package carton for these five lots displays an incorrect expiration date that is two months past the actual expiration date. The actual expiration of the individual Positioning Balloon Catheter and Micro-Catheter Lancet contained within the outer carton is correctly displayed on the pouch and box labels of those components. No adverse health consequence is expected to occur from this issue. The manufacturer has not received any complaints for the incorrect expiration date. Affected users are advised to immediately discontinue use of, segregate and return affected products.

According to the local supplier, the affected products were not distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 11 Sep 2014