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Terminated

Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

FDA Recall Z-1570-2009 · Posted 2009-06-30

Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeMLR
Date Initiated2009-01-12
Date Terminated2011-12-28
Product Quantity1,151 units.

Reason for Recall

The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.

Firm Action

Advanced Sterilization Products (ASP) sent an "Urgent: Product Correction" letter dated January 12, 2009 to each consignee informing them of the issue and instructed them to report smoke or a burning odors in or around their STERRAD 50 System. ASP strongly recommended for consignees to follow their facility's safety protocols and if possible, immediately disconnect the STERRAD 50 System from its electrical source. Customers were instructed to contact ASP to schedule an onsite visit to investigate the issue. If the issue is caused by a malfunctioning capacitor in the vacuum pump, the firm will replace the malfunctioning component right away. To correct this situation, an ASP Field Service Engineer (FSE) will visit all customers facilities within the next sixty days to replace the capacitor in the vacuum pump on the affected STERRAD 50 System.

Root Cause

Other

Distribution Pattern

Worldwide Distribution -- US, Germany, Italy, France, United Kingdom, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Belgium, Puerto Rico, Mexico, Philipines, Australia, Japan, Korea, Malaysia, Taiwan, Middle East, Peru, Canada, Czech Republic, Portugal, Spain, Sweden, Hungary, Poland, Brazil, Russia, Finland, Norway, Panama and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981625STERRAD 50 STERILIZERAdvanced Sterilization Products · 1999-01-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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