Class 2 Device Recall Compact Absorbers

• Date Initiated by Firm: September 11, 2006
• Date Posted: December 19, 2006
• Recall Status: Terminated on December 17, 2011
• Recall Number: Z-0291-2007
• Recall Event ID: 36326
• 510(K)Number: K973985
• Product Classification: anesthesia gas absorber - Product Code BSZ
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Datex - Ohmeda, Inc; 3030 Ohmeda Drive; PO Box 7550, zip 53707-7550; Madison WI 53707-7550
• Manufacturer 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.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BSZ