Device Recall STERRAD 50 의 리콜

Recall

51413

Class 2

Z-1419-2009

2009-03-09

2009-06-15

Terminated

United States

2012-03-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80227

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.

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.