STERRAD 50 Sterilization System Product Code 10050 recallZ-1419-2009 · Advanced Sterilization Products · initiated Mar 9, 2009

Why it was recalled

ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs.

FDA root cause category: Component design/selection

What the company is doing

Firm mailed out Urgent Device Correction letters dated March 9, 2009, advising customers/users that on April 23, 2008, Advanced Sterilization Products (ASP) initiated a device correction notification related to certain models of STERRAD Sterilization Systems that have the potential to emit oil mist due to a premature mechanical failure in the oil mist filter and/or filter assemblies. All affected STERRAD Systems have been corrected since the notification was issued. Recently, a secondary, lower-occurring cause of oil mist has been identified within the STERRAD NX System and STERRAD 50 System oil fill plugs. STERRAD NX System and/or STERRAD 50 System may potentially have defective oil fill plugs. Less than 1% of the installed STERRAD NX Systems have been affected. ASP has received 18 complaints in 10 months related to this failure for the STERRAD NX System. No complaints related to this issue for the STERRAD 50 System have been received. As of December 22, 2008, ASP has been actively replacing the plugs in these systems with stainless steel plugs during service calls and will continue to replace the oil fill plugs until all affected units are corrected. The letter advises that there is a risk of symptoms, such as nausea, shortness of breath, dry throat, burning, watery and blurry eyes, and headache occurring if customers inhale oil mist. If you see mist, haze or smoke in the room or detect an oil odor, personnel should complete the following: - Cancel the cycle if the sterilizer is running and as always, do not use instruments from an incomplete cycle - Leave the room - Avoid working in the room until the mist has cleared - Discontinue use of the STERRAD System until the system is repaired. Any additional questions can be directed to the Clinical and Technical Support staff at 1-888-4613.

Recall details

Recall number

Z-1419-2009

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Mar 9, 2009

Posted by the FDA

Jun 15, 2009

Recalling firm

Advanced Sterilization Products

Quantity

2,209 units installed in US; 2013 units OUS

Product code

FLF

FDA submissions

K023290, K981625

Distribution

Worldwide Distribution -- USA, Germany, Italy, France, UK, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Thailand, Taiwan, Turkey, Middle East, Peru, Canada, Czech Republic, Portugal, South Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.

Product description

STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Other devices under the same FDA submission

2 devices cleared under K023290, K981625 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Sterrad 10101

  Advanced Sterilization Products Services Inc. · Sterilizer, ethylene-oxide gas
  258 reports
• STERRAD™ 10113

  Advanced Sterilization Products Services Inc. · Sterilizer, chemical
  2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 51413).

• Z-1420-2009 · Terminated
  STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive r…