FDAClass IFebruary 19, 2020

PneumoDart recall

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…

Why was PneumoDart recalled?

A defect involving an occluded needle was discovered during a training exercise.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

NSN 6515-01-655-9514 Lot number - 190524J69 Expiration Date - May 24, 2026

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…
Recalling firm
Tytek Medical Inc
Quantity
3,565 units
Distribution
US (nationwide), and countries of: Europe, Australia and Hong Kong.
Recall date
February 19, 2020
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls