FDA Device

Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled

Hazard

Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD and bounced back during loading which could cause injury to consumers.

What You Should Do

Remedy

Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners MODEL: 6392, due to complaints and service reports that some cots compatible with the Performance-LOAD cot fastening system may not have been securely fastened or had an inability to fasten into the Performance-LOAD (bounced back during loading) which could lead to injury of consumers. Customer notification letters were sent via Fedex on November 8, 2016. Customers were asked to quarantine the impacted devices and submit completed business reply forms by fax (269)488-8691 or email productfieldaction@stryker.com. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the modification/repair of your Performance-LOAD unit to ensure that the unit securely fastens the cot within the ambulance. 4. In the interim, until the service can be performed, there are additional actions that users can and should take to ensure that the cot is securely fastened into the Performance-LOAD system. a. Per the PerformanceLOAD Operations Manual (P/N 6392-009-001, pages 26-27. If customers have loaned or sold any of the products listed in this letter, please forward a copy of the recall notice to the new users and advise Stryker of their new location in the space provided on the business reply form. If you have any questions or concerns, please contact Stryker Customer Service (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST).

Products

Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled
Brand
Stryker Medical Division of Stryker Corporation
UPC
Model(s): 6392-000-001, 6392-000-002, 6393-000-003, 6393-000-004; GTIN: 07613327282542, 07613327282603, 07613327282597, 07613327282610

Units Affected

749 units