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.
FDA Recall Z-2240-2011 · Posted 2011-05-23
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Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeIKY
Date Initiated2011-04-29
Date Terminated2011-10-07
Product Quantity213
Reason for Recall
Affected mattresses may not conform to federal flammability standards.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution - USA including California and the country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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