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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Toga

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  Class 2 Device Recall Stryker Toga see related information
Date Initiated by Firm February 23, 2018
Create Date April 24, 2018
Recall Status1 Terminated 3 on May 23, 2019
Recall Number Z-1500-2018
Recall Event ID 79779
510(K)Number K070078  
Product Classification surgical gown - Product Code FYA
Product T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000
Sterile personal protection garment
Code Information 17071877
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kara Spath
269-323-7700
Manufacturer Reason
for Recall		 Separation of material layers may occur, causing a potential risk of exposure to contaminants.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On March 7, 2018 Stryker Instruments mailed Urgent Medical Device Recall Notifications to affected customers. Distributors and Sales Representative were notified via e-mail. Customers were instructed to: 1) Immediately review this Recall Notification; 2) Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any affected T4 and T5 Togas; 3) Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Fax the completed BRF to Stryker Instruments at 866-521-2762, or email to kara.spath@stryker.com. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification; 4) If you have further distributed this product, please forward this Notification and the attached BRF to all affected locations. Please indicate each location on the BRF; 5) If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you and should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. Customer with questions or concerns may call (800)253-3210.
Quantity in Commerce 34,570 total products
Distribution US Nationwide and Ireland, Japan, South Korea, UK
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 INSTRUMENTS, INSTRUMENTS DIV.
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