A3/A5 Anesthesia Delivery System 의 리콜

Recall

63314

Class 1

Z-0291-2013

2012-08-13

2012-11-16

Terminated

United States

2013-06-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113482

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.

The firm, Mindray DS USA Inc., sent an "URGENT: A3/A5 ANESTHESIA DELIVERY SYSTEM CORRECTIVE ACTION" letter dated August 13, 2012 to their customers via Certified Mail return receipt requested. The letter described the product, problem and actions to be taken. The customers were instructed to route this letter to all potential uses of the product within their facility; increase fresh gas flow, should the leak occur during use, to compensate for any pressure loss resulting from the leak; alternatively, the absorber canister may be unlocked and locked again to reseat the gasket and verify that the canister and gasket are fully seated, a leak test is performed after replacement of the Pre-Pak or loose-fill absorbent and also be performed before each patient use until the canister gaskets are replaced on systems in their facility. A Mindray Representative will replace the canister gasket to correct the issue. If you have any questions or need to arrange for a replacement of the absorber canister gasket on the A3/A5 System(s) in your facility, contact your Mindray Service Representative, at 1-800-288-2121 (Monday-Friday 8:30am-5:30pm). A press release was issued by the firm on 11/14/2012.