FDAClass IIApril 4, 2018

DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for recall

DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow…

Why was DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for recalled?

Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

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?

Model # M1107626 Mfg. Lot or Serial #: BEJN05568, BEJM03853, BEJM04539, BEJN05793, BEJP01947, BEJP03924, BEJP04380, BEJP08533, BEJU06631, BEJN06095, BEJP04706, BEJU05053, BEJM04542, BEJM04881, BEJM04901, BEJN07748, BEJN07849, BEJP03230, BEJP03239, BEJP03559, BEJP03984, BEJP05309, BEJP05347, BEJP05825, BEJP05834, BEJP05978, BEJP08567, and BEJP09304.

Product
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow…
Recalling firm
GE Healthcare, LLC
Quantity
28
Distribution
US Distribution to states of: AZ, IL NC, NH and PA.
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls