Recall record at a glance
| Official record | Z-2959-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Steris Corporation |
| Report date | Sep 12, 2018 |
| Recall initiation date | Jul 26, 2018 |
| Quantity | 2889 units |
| Location | Mentor, OH, United States |
Official product description
AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices in Healthcare Facilities.
Why the product was recalled
There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.
Distribution information
Worldwide Distribution: US(nationwide) and to countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Belarus, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Nepal, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Suriname, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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