Tytek Medical Inc PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
Brand
Tytek Medical Inc
Lot Codes / Batch Numbers
NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026
Products Sold
NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026
Tytek Medical Inc is recalling PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction due to A defect involving an occluded needle was discovered during a training exercise.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A defect involving an occluded needle was discovered during a training exercise.
Recommended Action
Per FDA guidance
On November 15, 2019, Tytek Medical issued an Urgent Medical Device Recall notices and Return Response forms to customers. Customers were advised to take the following actions: 1) Please do not use any of the product from the affected lot. 2) Please recall this product from your points of distribution and return it immediately. 3) Product may be returned to Tytek Medical via UPS Account # R5513V or DHL Account # 958855282 to: Tytek Medical 4700 Ashwood Drive Ste 445, Cincinnati, OH 45241; (513) 874-7326 4) Complete and return the Instructions for Acknowledgement form via fax to (513) 874-7294; or via email to Stacey@tytekgroup.com Customers with questions or concerns may call (513) 872-7326 Monday through Friday 8 am - 5 pm, EST.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026