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U.S. Department of Health and Human Services

Class 2 Device Recall T4 Hytrel Zipper Toga

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  Class 2 Device Recall T4 Hytrel Zipper Toga see related information
Date Initiated by Firm June 01, 2012
Date Posted June 14, 2012
Recall Status1 Terminated 3 on April 14, 2014
Recall Number Z-1810-2012
Recall Event ID 61848
510(K)Number K944393  
Product Classification Gown, surgical - Product Code FYA
Product 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.
Code Information Part 0400-821-000, 0400-841-000,and 0400-851-000 all lots  
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Angela Ragainis
269-389-4354
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action Stryker sent the May 29,2012 URGENT MEDICAL DEVICE RECALL NOTIFICATION and the June 14, 2012 REVISED URGENT MEDICAL DEVICE RECALL Notice to all consignees. The letters identified the affected products, problem and actions to be taken. The Revised letter instructed customers to find, quarantine, make product unusable and destroy all implicated product . Replacement products may not immediately available. Customers were asked to complete and sign the Business Reply Form (BFR) and fax to Stryker Instruments Regulatory Department at 866-521-2762. If the affected products have been further distributed, forward this notification letter and the attached BRF to all affected locations. Questions should be addressed to Angela Ragainis, 269-389-4354; angela.ragainis@stryker.com
Quantity in Commerce 16, 846 (last 3 years) 35,492 all years
Distribution 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
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = FYA and Original Applicant = STRYKER CORP.
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