Events

Safety Alert for Encore 26 Inflation Device Single Pack

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Boston Scientific.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-06-20
  • Event Date Posted
    2017-06-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170620a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: boston scientific encore 26 inflation device single pack medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its encore 26 inflation device single pack. the affected products [upn & lot numbers] are listed below:- upn: h74904526011; lot numbers: 19563006, 19587644, 19623142, 19650458, 19704550, 19725489, 19769215, 20054530, 20077271, 20083051, 20127928, 20159518, 20202728, 20206930, 20242335, 20285571, 20309573, 20309574, 20336380, 20394218, 20423644, 20423645, 20456071, 20481170, 20534557 upn: m001151050; lot numbers: 19640750, 19667072, 19704551, 19755302, 19755307, 19785021, 19808183, 20030825, 20060033, 20087896, 20117909, 20159601, 20171449, 20206929, 20233700, 20256035, 20279769, 20303751, 20336385, 20336386, 20364928, 20364929, 20364930, 20423650, 20472532, 20493563, 20507373, 20534581 upn: m00566670; lot numbers: 20157078, 19623019, 19755304, 20056496, 20146417, 20264032, 20456079 upn: m0067101140; lot numbers: 19594194, 19717352, 19808180, 20121252, 20223176, 20336387, 20394350, 20534582 the manufacturer is implementing a field action on specific lots of encore 26 inflation device single packs. the device trays of certain lots have the potential to crack under certain handling conditions, such as impact during shipment. this issue has been attributed to a change in the material used in the packaging process. the complaints received for this issue have shown that this cracking, which is observed at a low rate (approximately 0.026%), only occurs on one section of the device tray potentially causing a sterile barrier breach. this field action only affects the single pack encore 26 inflation device. it does not affect encore advantage kits, encore five (5) packs or other kits containing the encore device. affected users should inspect the device tray. if they identify any units with a cracked tray, they should immediately discontinue use and segregate the affected units in a secure location. if no damage is identified, the device may be used as normal. product replacement is on-going. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 june 2017.

Device

Encore 26 Inflation Device Single Pack
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Encore 26 Inflation Device Single Pack
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH