Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE

FDA device recall Z-0291-2007 · posted 2006-12-19 · Terminated

Recall details

Recalling firm

Datex - Ohmeda, Inc

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

BSZ

Quantity affected

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, Por

Date initiated

2006-09-11

Date posted

2006-12-19

Date terminated

2011-12-17

Location

Madison, WI

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