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FDAOctober 22, 2018device

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 PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic e...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

wom worldwom

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic e... — Recall Details · AllClear