Events

Recall of Device Recall Stryker EMS Stair Pro Evacuation Chair

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

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
    59112
  • Event Risk Class
    Class 2
  • Event Number
    Z-3011-2011
  • Event Initiated Date
    2011-06-28
  • Event Date Posted
    2011-08-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101241
  • 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
    Stretcher, hand-carried - Product Code FPP
  • Reason
    This recall was initiated as the firm ascertained the supplier may have reworked some of the red release bars used during the time frame of 22 december 2010 through 31 january 2011. the rework subjected the parts to excessive heat and as a result, the bars can bend during the action of squeezing the release bar against the black cross tube to release the track. the red release bars may bend to.
  • Action
    The firm, Stryker Medical, sent an "Urgent-Medical Device Recall" letter dated June 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate the listed product; inspect each unit prior to use; return the enclosed post card to confirm receipt of this notification; if they have loaned or sold any of the chairs listed, forward a copy this letter to the new users and advise Stryker of new users names and locations, and if they have disposed of any of the affected chairs and they are no longer in use, advise Stryker of their obsolescence by providing them with the serial numbers. Stryker stated in the letter that, their goal is the timely upgrade of all affected units within the next 90 days. If you have any questions or concerns, please contact us at 800-STRYKER, option 2. Please reference RA-2011-027. Normal business hours are Monday-Friday 8am-5pm EST.

Device

Device Recall Stryker EMS Stair Pro Evacuation Chair
  • Model / Serial
    Model 6252, Lot numbers 110142628, 110142635, 101240404, 110143805, 101240405,110142848, 110143293, 110142846, 110142847, 110142849, 110142850, 110142851, 110142830, 110142887, 110142898, 110143270, 110143752, 110142828, 110142637, 110142826, 110142827, 110143299, 101240406, 101240447, 110143816, 101241853, 101241854, 101241855, 110143261, 110142607, 110142608, 110142609, 101240117, 101241850, 101241851, 101241188, 101240147, 101240148, 110142601, 110142602, 110142636, 110142863, 101240998, 101240999, 101241000, 101241001, 101241002, 101241003, 101241004, 101241005, 101241006, 101241007, 101241008, 101240436, 101240804, 101240805, 101240806, 101240871, 101241857, 101240115, 110143285, 110143286, 110142864, 101241856, 110142612, 110142654, 110142655, 110142656, 110142657, 110142658, 110142659, 110142660, 110142661, 110142662, 110142663, 110142664, 110142626, 110142627, 110142838, 110142839, 101240407, 101241862, 110142800, 110142801, 110143253, 110143294, 110142603, 110142886, 110143761, 101241125, 110142605, 110142832, 110142833, 110142834, 110142835, 110142836, 101240886, 110142629, 101240116, 110143289, 110142831, 101240403, 101240401, 110142610, 110142611, 110143762, 110143290, 110143820, 110143821, 101241127, 110142600, 110143836, 110142837, 101240885, 101240445, 101241199, 101240874, 101240875, 101240876, 101240877, 101240878, 101240879, 110143292, 110142606, 110143844, 110143845, 110143846, 110143847, 101241190, 101240873, 110142640, 110143287, 101240444, 110142825, 101241858, 101241859, 110142899, 101240402, 101241852, 110142845, 110142644, 110142645, 110143295, 110143848, 101240872, 101240887, 101240888, 101240889, 101240890, 101240891, 110143817, 110143818, 110143819, 110143245, 110143246, 110143247, 110143248, 110143249, 110143806, 110143807, 110143808, 110143809, 110143810, 110142885, 110143768, 110143769, 110143770, 110143771, 110143772, 110143773, 110143774, 110143775, 110143776, 110143777, 110143778, 110143779, 110143780, 110143781, 110143782, 110143783, 110143784, 110143785, 110143786, 110143787, 110143788, 110143789, 110143790, 110143791, 110143792, 101241189, 110143837, 110143838, 101241111, 101241112, 110143298, 110142639, 101241860, 101241861, 110142803, 101241187, 110142614, 110143296, 110142643, 101241114, 101241115, 110142829, 110143759, 110143760, 101240446, 101240899, 110142641, 110142642, 101240448 and 110143288.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden.
  • Product Description
    Stryker EMS Stair - Pro Evacuation Chair Model 6252 || It Is intended to aid in the transportation of passengers up and/or down a flight of stairs in an evacuation situation.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Division of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA