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U.S. Department of Health and Human Services

Class 2 Device Recall Hytrel Toga

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 Class 2 Device Recall Hytrel Toga see related information
Date Posted June 06, 2013
Recall Status1 Terminated on April 14, 2014
Recall Number Z-1493-2013
Recall Event ID 65321
510(K)Number K070078 
Product Classification Gown, surgical - Product Code FYA
Product Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use;

Product Usage:
Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
Code Information 1006134, 1012304, 1104308, 1007152, 1101020, 1105365, 1007170, 1102080, 1106421, 1008188, 1102147, 1106469, 1009205, 1103193, 1108628, 1010229, 1103198, 1108697, 1010253, 1102149, 1109789, 1011277, 1104248
Recalling Firm/
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact
Manufacturer Reason
for Recall
Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
FDA Determined
Cause 2
Nonconforming Material/Component
Action Stryker sent an Urgent Urgent Recall noitifications letter dated May 7, 2013 via certified US mail and E-mail l to all affected customers, distributors and direct accounts. The letter identified the affected products, problem, risk to health, and actions to be taken. Customers were instructed to check inventory, immediately quarantine any affected product, and open each package before discarding to prevent use. Customers were directed to fill out and return a Business Reply Form to Stericycle, Phone: 888-943-2396 Fax: 888-943-4192, Email: stryker5893@stericycle.com verifying directions and confirming recalled product was destroyed. For questions call 269-389-4354 or 269-389-4518.
Quantity in Commerce 34,640 units (3,464 boxes)
Distribution USA Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FYA and Original Applicant = STRYKER INSTRUMENTS, INSTRUMENTS DIV.