TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
Recall
- Recall Number
- Z-2610-2023
- Event Number
- 92899
- Firm
- Tytek Medical Inc
- FEI Number
- 3004551550
- Product Code
- GAA
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 5, 2020
- Posted
- September 19, 2023
- Terminated
- March 13, 2026
- Address
- 8904 Beckett Rd, West Chester, OH, 45069-7054
Description
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
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.
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439146 units