Z-0930-2020Class I

PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the...

Name: Z-0930-2020 PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the...
Creator: Tytek Medical Inc
Published: 2019-11-15
License: https://open.fda.gov/license/

Tytek Medical Inc / initiated 2019-11-15 / Terminated / root cause: manufacturing process

FDA source

Tytek Medical Inc began a recall of 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... on 2019-11-15. FDA classified it as Class I and gives the reason as "A defect involving an occluded needle was discovered during a training exercise". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0930-2020
Classification: Class I
Status: Terminated
Initiated: 2019-11-15
Posted: 2020-02-12
Terminated: 2020-10-01
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.
Product code: BWC Needle, Emergency Airway
Reason for recall: A defect involving an occluded needle was discovered during a training exercise.
Root cause tag: manufacturing process
FDA 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 [email protected] Customers with questions or concerns may call (513) 872-7326 Monday through Friday 8 am - 5 pm, EST.
Quantity in commerce: 3,565 units
Distribution: US (nationwide), and countries of: Europe, Australia and Hong Kong.
Product codes and lots: NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0930-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0930-2020	Class I	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-12

Product code BWC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)