STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Ster

FDA device recall Z-0340-2009 · posted 2008-11-21 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

Reason for recall

1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injection of insufficient hydrogen peroxide sterilant and 2) Inability of the sterilizer to detect an obstruction in the door travel path while the door is closing. This situation can result in a hand b

Action taken

Customer notifications will be sent the week of November 24, 2008. The notification letter (URGENT: Product Correction) will advise of two situations that could cause the STERRAD 100S Sterilizer to malfunction. The first situation involves the failure of the STERRAD 100S System to detect when an injection takes place without hydrogen peroxide having been transferred to the vaporizer bowl. This can occur under combinations of the following conditions: - the pneumatic pressure is low on the machine, or - the injector valve has a small leak, AND - a cassette fails to advance, or - a used cassette is re-inserted into the sterilizer. This situation can result in a cycle completion with insufficient hydrogen peroxide. The second situation involves the failure of the STERRAD 100S System to detect an obstruction in the door travel path while the door is closing. Under some conditions, the door sensors may become mechanically unsecured/disconnected and will not detect an obstruction. This situation can result in an operator's hand becoming pinched and bruised while the door is closing. To correct both situations above, Advanced Sterilization Products(ASP) has revised the software and is making physical hardware additions to the STERRAD 100S System. Contact ASP Customer Care Center at 888-783-7723, option 2 for questions or assistance.

Root cause

Component design/selection

Status

Terminated

Product code

MLR

Quantity affected

In the U.S., there are 2,623 units installed. There are also 3,701 units internationally.

Distribution

Worldwide Distribution including USA and countries of France, Germany, Italy, UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indone

Date initiated

2008-10-17

Date posted

2008-11-21

Date terminated

2011-11-29

Location

Irvine, CA

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