STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The

FDA device recall Z-0043-2014 · posted 2013-10-22 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

Reason for recall

Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.

Action taken

A customer notification letter was sent on September 18, 2013, to all customers who received the STERRAD 200 Sterilization System. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to indicate if they have received a STERRAD 200 System and to report any complaints or suspected problems to Advanced Sterilization Products (ASP) Professional Services directly at (888) 783-7723 and select option #2. An alternate design for the oil mist filter is being developed and qualification of new vacuum pump oil is in process. This action is to modify the PM interval to service the filter and oil more frequently. This will serve as an immediate/interim solution to reduce incidence of odor/smell complaints until the new oil mist filter design and vacuum pump oil are released. A Customer Letter will be sent to all STERRAD 200 customers to notify them of the issue and the corrective actions we are taking to resolve this issue.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MLR

Quantity affected

1,305 units total (654 units in US , 651 OUS )

Distribution

Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada

Date initiated

2013-09-18

Date posted

2013-10-22

Date terminated

2014-04-11

Location

Irvine, CA

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