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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Event Detail

Event ID 61848
Product Type Devices
Status Ongoing
Recalling Firm Stryker Instruments Div. of Stryker Corporation
City Portage
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-01
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - US (nationwide) including the states of: AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the country of SWITZERLAND

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. Part 0400-821-100, 0400-841-100 , 0400-851-100 0400-851-100S1, and 0400-851-100S2 all lots Class II The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids. 23,653 ( past 3 years) 47937 all years Z-1809-2012
T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. Part 0400-821-000, 0400-841-000,and 0400-851-000 all lots Class II The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids. 16, 846 (last 3 years) 35,492 all years Z-1810-2012
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