Recall Z-2240-2011 ยท IKY Mattress, Flotation Therapy, Non-Powered
Stryker Medical Division of Stryker Corporation
Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI. The Impression non-powered mattress is recommended for use in the prevention of pressure ulcers. It is intended for use on Stryker frames and on other frames supporting a 84" x 35" x 6" mattress.
| Date | May 23, 2011 (initiated Apr 29, 2011) |
| Status | Terminated |
| Reason | Affected mattresses may not conform to federal flammability standards. |
| Root cause | Other |
| Action | Stryker Medical sent an URGENT MEDICAL DEVICE RECALL letter dated April 29, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate all affected mattresses , remove the existing mattress cover, and replace it with an enclosed mattress cover. Customers were then to notify Stryker to confirm repairs. If the mattresses were loaned or sold, Stryker requested customers to notify the new user of the recall. Customers with questions or concerns, were asked to call 269-389-6689. |
| Quantity | 213 |
| Distribution | Worldwide Distribution - USA including California and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.