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
Reported: September 27, 2023 Initiated: October 5, 2020 #Z-2612-2023
Product Description
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
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
Details
- Recalling Firm
- Tytek Medical Inc
- Units Affected
- 22,026 units
- Distribution
- OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
- Location
- West Chester, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Tytek Medical Inc. Units affected: 22,026 units.
Why was this product recalled? ▼
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 27, 2023. Severity: Moderate. Recall number: Z-2612-2023.
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