FDA Medical Device Recalls (openFDA)
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 number
- Z-0930-2020
- Recalling firm
- Tytek Medical Inc
- 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.
- Status
- Terminated
- Initiated
- 2019-11-15
- Posted
- 2020-02-12
- Terminated
- 2020-10-01
- Reason
- A defect involving an occluded needle was discovered during a training exercise.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 3,565 units
- Distribution
- US (nationwide), and countries of: Europe, Australia and Hong Kong.
- Lot, serial or model codes
- NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BWC
- Firm FEI
- 3004551550
- Firm city
- Blue Ash
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28