Recall Z-3010-2011 ยท FPP Stretcher, Hand-Carried
Stryker Medical Division of Stryker Corporation
Stryker Evacuation Chair Model 6254 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 | Some of the red release bars used during the time frame of 22 December 2010 through 31 January 2011 were reworked. 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 the degree that they permanently engage the track locking mechanism |
| 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 | 220 |
| 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.