Stryker, Impression, Non-Powered Mattress, Model 2980, Stryker Medical, Portage, MI. The Impression non-powered mattress

FDA device recall Z-2240-2011 · posted 2011-05-23 · Terminated

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

Affected mattresses may not conform to federal flammability standards.

Action taken

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

Status

Terminated

Product code

IKY

Quantity affected

213

Distribution

Worldwide Distribution - USA including California and the country of Canada.

Date initiated

2011-04-29

Date posted

2011-05-23

Date terminated

2011-10-07

Location

Portage, MI