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.
Enforcement
- Recall Number
- Z-1809-2012
- Event ID
- 61848
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Instruments Div. of Stryker Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 20, 2012
- Initiation Date
- June 1, 2012
- Classification Date
- June 14, 2012
- Termination Date
- April 14, 2014
- Address
- 4100 E Milham Ave, Portage, MI, 49002-9704, United States
Description
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.
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.
Part 0400-821-100, 0400-841-100 , 0400-851-100 0400-851-100S1, and 0400-851-100S2 all lots
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
23,653 ( past 3 years) 47937 all years