TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patien
Summary
The FDA issued a Class II for TyTek PneumoDart- Intended for introduction into the body to facilitate removal by Tytek Medical Inc. Reason: Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site.
Details
Source
Device Recall
External ID
Z-2612-2023
Action Date
2023-09-27
Status
Terminated
Category
device
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
Lot/Code Info: UDI: 00855204008167 All lots produced prior to Oct 5, 2020
Quantity Affected: 22,026 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
Distribution
OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK
Type: Voluntary: Firm initiated
Recall Initiated: 2020-10-05
Company
West Chester, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tytek Medical Inc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tytek Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tytek Medical Inc have FDA actions?
Tytek Medical Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2612-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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