Events

Recall of Device Recall Stryker Infravision

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Endoscopy.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56357
  • Event Risk Class
    Class 2
  • Event Number
    Z-1002-2011
  • Event Initiated Date
    2010-05-11
  • Event Date Posted
    2011-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93290
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    endoscopy accessory - Product Code FAT
  • Reason
    The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.
  • Action
    On 5/11/10, Stryker Endoscopy initiated the recall notification letters explaining the reason for the recall and requesting the product be returned.

Device

Device Recall Stryker Infravision
  • Model / Serial
    PSTR010710-1, PSTR081109-1, PSTR081109-2, PSTR081209-1, PSTR081309-2,  PSTR082109-1, PSTR082709-1, PSTR082809-1, PSTR090809-1, PSTR091809-1,  PSTR091809-2, PSTR092409-1, PSTR100309-1, PSTR100909-1, PSTR110609-1,  PSTRI20709-2, PSTR121809-1, PSTR122209-1, STR021009-8R, STR022709-1R,  STR022709-2R, and STR041709-4R
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and 3 foreign consignees (Canada, Singapore and Switzerland).
  • Product Description
    Stryker Endoscopy, Infravision Esophageal Kit, || Model Numbers: 220180548, 220180540, 220180560
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA