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Terminated

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

FDA Recall Z-2612-2023 · Posted 2023-09-19

Recalling FirmTytek Medical Inc
Recall StatusTerminated
Product CodeGAA
Date Initiated2020-10-05
Date Terminated2026-03-13
Product Quantity22,026 units

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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