TyTek PneumoDart- Intended for introduction into the recall
TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax…
Why was TyTek PneumoDart- Intended for introduction into the 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00855204008167 All lots produced prior to Oct 5, 2020
- Product
- TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax…
- Recalling firm
- Tytek Medical Inc
- Quantity
- 22,026 units
- Distribution
- OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
- Recall date
- September 27, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)