FDAClass IIApril 4, 2018

DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are recall

DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.

Why was DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are 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 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187

Product
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Recalling firm
GE Healthcare, LLC
Quantity
2
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