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Recall Observatory FDA recall evidence

Device product

Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled

Z-0739-2017

November 08, 2016

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 75820
Status
Terminated
Classification
Class II
Quantity
749 units
Official record key
device-enforcement:Z-0739-2017

Official wording

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.

Code information: Model(s): 6392-000-001, 6392-000-002, 6393-000-003, 6393-000-004; GTIN: 07613327282542, 07613327282603, 07613327282597, 07613327282610

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.