Datex - Ohmeda, Inc: Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411.

Recall number

Z-0291-2007

Recalling firm

Datex - Ohmeda, Inc

Product

Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411.

Status

Terminated

Initiated

2006-09-11

Posted

2006-12-19

Terminated

2011-12-17

Reason

Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia.

Root cause

Other

Action

All customers were contacted by letter in September 2006, and provided with a customer reply form. The firm sales some of the Compact Absorbers to distributors and they were asked to notify their Compact Absorber customers. Customers outside the US will be contacted to the end user and then their dealers and distributors. The letter said to immediately discontinue the use of all Compact Absorbers having a lot number as identified (reference codes 427002100 - white to violet color change) and (42700200 - pink to white color change). The affected lot numbers should be isolated and destroyed. Once the Product Verification Form has been received by Fax, Multi-Absorbers or when replacement Compact Absorbers are available will be shipped to customers free of charge.

Quantity

670,620

Distribution

Worldwide, including USA, Austria, Australia, Belgium, Canada, Croatia, Germany, Denmark, Finland, France, Greece, Iceland, Ireland, Italy, Japan, South Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Lot, serial or model codes

The lot number is always a six-digit number, where the first digits indicate the manufacturing sub-batch during the month and the last three digits indicate the month and year of the manufacture (MMY). The last three digits indicating month and year of manufacture are most significant. For example, a lot number ending in 086 indicates that this lot was manufactured in August 2006.  -All lots manufactured in July, 2006 (076) or earlier are affected.  -Compact Absorbers from lot numbers 133086 and 136086, manufactured in August, 2006, should be isolated and destroyed. All other lots manufactured in August 2006 (086) are acceptable for use.  -All lots manufactured in September 2006 (096) or later are acceptable for use.

510(k) numbers

["K973985"]

PMA numbers

not on file

Product code

BSZ

Firm FEI

2183066

Firm city

Madison

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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