Recall Z-3011-2011
Stryker Medical Division of Stryker Corporation · initiated June 28, 2011
Product
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.
Codes / lots: 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…
Reason for recall
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
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-3011-2011
- Initiated
- June 28, 2011
- Posted by FDA
- August 11, 2011
- Terminated
- August 29, 2013
- Product code
- FPP – Stretcher, Hand-Carried
- Quantity
- 214
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden.
- Recalling firm
- Stryker Medical Division of Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3010-2011 | Stryker Evacuation Chair Model 6254 It Is intended to aid in the transportation of…Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were… | 06/28/2011Terminated |