Recall record at a glance
| Official record | Z-0290-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Report date | Nov 28, 2012 |
| Recall initiation date | Aug 13, 2012 |
| Quantity | 69 units (61 US - 8 Foreign) |
| Location | Mahwah, NJ, United States |
Official product description
Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.
Why the product was recalled
Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.
Distribution information
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement 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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