Z-2612-2023Class II

TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural...

Name: Z-2612-2023 TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural...
Creator: Tytek Medical Inc
Published: 2020-10-05
License: https://open.fda.gov/license/

Tytek Medical Inc / initiated 2020-10-05 / Terminated / root cause: design

FDA source

Tytek Medical Inc began a recall of TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model... on 2020-10-05. FDA classified it as Class II and gives the reason as "Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2612-2023
Classification: Class II
Status: Terminated
Initiated: 2020-10-05
Posted: 2023-09-19
Terminated: 2026-03-13
Recalling firm: Tytek Medical Inc
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
Product code: GAA Needle, Aspiration And Injection, Disposable
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
Root cause tag: design
FDA root cause: 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
Product codes and lots: UDI: 00855204008167 All lots produced prior to Oct 5, 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2612-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2610-2023	Class II	Terminated	Voluntary: Firm initiated	2023-09-27	2023-09-19
Z-2611-2023	Class II	Terminated	Voluntary: Firm initiated	2023-09-27	2023-09-19
Z-2612-2023	Class II	Terminated	Voluntary: Firm initiated	2023-09-27	2023-09-19

Product code GAA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)