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Class 2 Device Recall PerformanceLOAD Ambulance Cot Fastener |
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Date Initiated by Firm |
November 08, 2016 |
Create Date |
December 12, 2016 |
Recall Status1 |
Terminated 3 on January 16, 2018 |
Recall Number |
Z-0739-2017 |
Recall Event ID |
75820 |
Product Classification |
Stretcher, wheeled - Product Code FPO
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Product |
Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled |
Code Information |
Model(s): 6392-000-001, 6392-000-002, 6393-000-003, 6393-000-004; GTIN: 07613327282542, 07613327282603, 07613327282597, 07613327282610 |
Recalling Firm/ Manufacturer |
Stryker Medical Division of Stryker Corporation 3800 E Centre Ave Portage MI 49002-5826
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For Additional Information Contact |
Renata Sila 269-324-6609
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Manufacturer Reason for Recall |
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.
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FDA Determined Cause 2 |
Under Investigation by firm |
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 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). |
Quantity in Commerce |
749 units |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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