STERRAD 50 Sterilization System, Product Code 10050 recallZ-1629-2008 · Advanced Sterilization Products · initiated Feb 25, 2008

Why it was recalled

Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke."

FDA root cause category: Device Design

What the company is doing

The firm sent an Urgent Device Correction letter dated 4/23/08, notifying customers of a situation that may occur with all models of STERRAD Sterilization Systems (100S, 50, 200, NX and 100NX). As a precaution, personnel should leave the room if mist is observed and avoid returning until the mist has cleared. ASP asks that customers circulate this letter to any STERRAD system users within their facility and also to the Chief Administrative Officer, the Director of Biomedical Engineering, Director of Materials Management and the Chief of Nursing. The letter instructs customers on what to do if they experience a filter failure - a) cancel the cycle if the sterilizer is running [and as always, do not use instruments from an incomplete cycle], b) leave the room, c) discontinue use of the STERRAD Sterilizer until the system is repaired. d) Personnel should avoid working in the room until the mist has cleared. The letter advises that ASP service will replace the sterilizer's filter and increase the frequency of filter changes by adjusting the Planned Maintenance (PM) schedule within the software on their STERRAD 100S and STERRAD NX Sterilizer. Per the notice, for each STERRAD Sterilizer model, ASP will do the following: a) STERRAD 200 Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter and gasket assembly at no charge. b) STERRAD NX Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter assembly at no charge and adjust the PM schedule to 650 cycles or 6 months (whichever occurs first). c) STERRAD 100S Sterilizer - beginning April 28, 2008 through October 2008, ASP will adjust the PM schedule to 750 cycles or 6 months (whichever occurs first). d) STERRAD 50 and 100NX Sterilizers - No adjustments to the oil mist filters or PM schedules are required at this time. PMs will be performed as currently scheduled. Information for MedWatch reporting is included in the letter.

Recall details

Recall number

Z-1629-2008

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Feb 25, 2008

Posted by the FDA

Aug 8, 2008

Recalling firm

Advanced Sterilization Products

Quantity

9,950

Product code

MLR

FDA submissions

K023290, K981625

Distribution

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

Product description

STERRAD 50 Sterilization System, Product Code 10050 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 47355).

• Z-1628-2008 · Terminated
  STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and moisture sensitive reusable medical devices.
• Z-1631-2008 · Terminated
  STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive reusable medical devices.
• Z-1632-2008 · Terminated
  STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive reusable medical devices.