FDAClass IIDecember 5, 2018

PNEUMOCLEAR Heated High-Flow Tube Set Product Usage recall

PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the…

Why was PNEUMOCLEAR Heated High-Flow Tube Set Product Usage recalled?

It is possible that the packaging of the product can be damaged by the prongs on the tube set.

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?

Lots from 4011926 to 4013513 (ALL)

Product
PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the…
Recalling firm
WOM World of Medicine AG
Quantity
124,180 tube sets
Distribution
Worldwide Distribution - US in the state of California and country of Netherlands
Recall date
December 5, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls