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U.S. Department of Health and Human Services

Class 2 Device Recall TyTek

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  Class 2 Device Recall TyTek see related information
Date Initiated by Firm October 05, 2020
Date Posted September 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-2612-2023
Recall Event ID 92899
Product Classification Needle, aspiration and injection, disposable - Product Code GAA
Product TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax
Model Number: TM-317
Code Information UDI: 00855204008167 All lots produced prior to Oct 5, 2020
Recalling Firm/
Tytek Medical Inc
8904 Beckett Rd
West Chester OH 45069-7054
For Additional Information Contact Jennifer Hollins
Manufacturer Reason
for Recall
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
FDA Determined
Cause 2
Device Design
Action TyTek New Product IFU was initially sent out to all who purchased the product on 08Dec2020 with notification on what was updated. An official field safety notice (FSN) was sent to customers on 02Aug2021.The changes to the IFUs were proactive in nature. There has been no change to the Products themselves. When used in a manner consistent with the IFUs, the Products are safe for their intended use, and we wish to reiterate that there have been no incidents whatsoever. For you reference I have attached the IFU that we originally sent you in December 2020. Please do not hesitate to contact us should you have any additional questions. The change in our IFUs for these products was implemented to: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location.
Quantity in Commerce 22,026 units
Distribution OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.