Reported Nov 28, 2012 · Terminated
Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ…
Mindray DS USA, Inc. d.b.a. Mindray North America
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. d.b.a. Mindray North America · 800 MacArthur Blvd. · Mahwah, NJ · 07430
Is this the product you have?
- Mindray A5 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.
- Lot codes and dates
- 0631F-01000-00 Various serial numbers
622 of 622 codes
0631F-01000-00EJ-1A0014110631F-01000-00EJ-1A0014260631F-01000-00EJ-1A0014310631F-01000-00EJ-1A0014390631F-01000-00EJ-1A0014430631F-01000-00EJ-1C0015770631F-01000-00EJ-1C0015920631F-01000-00EJ-1C0015930631F-01000-00EJ-1C0016220631F-01000-00EJ-1A0014690631F-01000-00EJ-1A0014160631F-01000-00EJ-1A0014230631F-01000-00EJ-1B0014970631F-01000-00EJ-1B0015190631F-01000-00EJ-1B0015240631F-01000-00EJ-1B0015380631F-01000-00EJ-1B0015440631F-01000-00EJ-1B0015460631F-01000-00EJ-1B0015490631F-01000-00EJ-1B0015500631F-01000-00EJ-1C0015720631F-01000-00EJ-1C0016170631F-01000-00EJ-220016840631F-01000-00EJ-1B0015400631F-01000-00EJ-1B0015480631F-01000-00EJ-210016340631F-01000-00EJ-210016410631F-01000-00EJ-210016420631F-01000-00EJ-210016440631F-01000-00EJ-21001650
- 0631F-01000-00 Various serial numbers
- Amount recalled
- 346 units (311 US - 35 Foreign)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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