Recall Z-3011-2011 ยท FPP Stretcher, Hand-Carried
Stryker Medical Division of Stryker Corporation
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.
| Date | Aug 11, 2011 (initiated Jun 28, 2011) |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | 214 |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Canada, China, France, Germany, India, Netherlands, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.