Recall record at a glance
| Official record | Z-0603-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Steris Corporation |
| Report date | Jan 13, 2016 |
| Recall initiation date | Nov 20, 2015 |
| Quantity | 2,319 units |
| Location | Mentor, OH, United States |
Official product description
AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
Why the product was recalled
The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature.
Distribution information
Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Bahrain, Canada, China, Colombia, Costa Rica, France, Hong Kong, India, Indonesia, Israel, Kuwait, Lebanon, Mexico, Panama, Peru, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, Viet Nam & Virgin Islands.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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