FDAClass IINovember 23, 2016

Atrium Medical 16 Fr Trocar catheter recall

Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or…

Why was Atrium Medical 16 Fr Trocar catheter recalled?

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

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?

All lot codes

Product
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or…
Recalling firm
Atrium Medical Corporation
Quantity
2172 cases (10/cs)
Distribution
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls