STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The ST

FDA device recall Z-0741-2012 · posted 2012-01-13 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

Reason for recall

ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over time.

Action taken

ASP will send an Urgent Medical Device Correction letter to all affected customers on January 23rd, 2012. The letter describes the product, problem and the actions to be taken. The letter informs customers that ASP has determined that the vacuum pump in the STERRAD 200 System may cause the emission of a slightly increased level of hydrogen peroxide (H2O2) vapor into the surrounding environment if not regularly serviced or replaced. The letter instructed customers to read the "Issue Description" and "Recommendations" sections in the letter, pass on the notice with any staff that work with or around the STERRAD 200, and maintain awareness of this communication until ASP has serviced the system. Also, a list of FAQ was provided. The letter states that ASP will replace, free of charge, the vacuum pumps on all STERRAD 200 Systems that have exceeded the pump manufacturer's recommended service interval. ASP has contracted with Stericycle to manage this field correction. Telephone numbers are provided in the letter: for questions related to this field correction, please contact Stericycle at 1-877-225-9750 and to report any complaints or suspected problems with the System, please contact ASP Professional Services directly at 1-888-783-7723, option # 2.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MLR

Quantity affected

395 units

Distribution

Worldwide Distribution - USA (nationwide)

Date initiated

2012-01-23

Date posted

2012-01-13

Date terminated

2013-09-23

Location

Irvine, CA

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