FDA Recall Terminated

Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled

Recall: Z-0739-2017 · Initiated November 8, 2016

Recall

Recall Number
Z-0739-2017
Event Number
75820
Firm
Stryker Medical Division of Stryker Corporation
FEI Number
1831750
Product Code
FPO
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
November 8, 2016
Terminated
January 16, 2018
Address
3800 E Centre Ave, Portage, MI, 49002-5826

Description

Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled

Reason

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.

Action

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 [email protected]. 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).

Distribution

Worldwide Distribution to AK, AL , AR , AZ , CA , CT , DC , DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA , RI, SC, TN, TX, UT,VA, VT ,WA ,WV ,WY and Internationally to Canada and the Netherlands

Quantity

749 units