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U.S. Department of Health and Human Services

Class 1 Device Recall A3/A5 Anesthesia Delivery System

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  Class 1 Device Recall A3/A5 Anesthesia Delivery System see related information
Date Initiated by Firm August 13, 2012
Date Posting Updated November 16, 2012
Recall Status1 Terminated 3 on June 04, 2013
Recall Number Z-0291-2013
Recall Event ID 63314
510(K)Number K102471  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product 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.
Code Information 0631F-01000-00, Various serial numbers

, 0631F-01000-00 EJ-1A001411, 0631F-01000-00 EJ-1A001426, 0631F-01000-00 EJ-1A001431, 0631F-01000-00 EJ-1A001439, 0631F-01000-00 EJ-1A001443, 0631F-01000-00 EJ-1C001577, 0631F-01000-00 EJ-1C001592, 0631F-01000-00 EJ-1C001593, 0631F-01000-00 EJ-1C001622, 0631F-01000-00 EJ-1A001469, 0631F-01000-00 EJ-1A001416, 0631F-01000-00 EJ-1A001423, 0631F-01000-00 EJ-1B001497, 0631F-01000-00 EJ-1B001519, 0631F-01000-00 EJ-1B001524, 0631F-01000-00 EJ-1B001538, 0631F-01000-00 EJ-1B001544, 0631F-01000-00 EJ-1B001546, 0631F-01000-00 EJ-1B001549, 0631F-01000-00 EJ-1B001550, 0631F-01000-00 EJ-1C001572, 0631F-01000-00 EJ-1C001617, 0631F-01000-00 EJ-22001684, 0631F-01000-00 EJ-1B001540, 0631F-01000-00 EJ-1B001548, 0631F-01000-00 EJ-21001634, 0631F-01000-00 EJ-21001641, 0631F-01000-00 EJ-21001642, 0631F-01000-00 EJ-21001644, 0631F-01000-00 EJ-21001650, 0631F-01000-00 EJ-21001643, 0631F-01000-00 EJ-21001654, 0631F-01000-00 EJ-22001704, 0631F-01000-00 EJ-23001760, 0631F-01000-00 EJ-23001765, 0631F-01000-00 EJ-23001775, 0631F-01000-00 EJ-1A001437, 0631F-01000-00 EJ-1A001445, 0631F-01000-00 EJ-22001710, 0631F-01000-00 EJ-22001724, 0631F-01000-00 EJ-22001743, 0631F-01000-00 EJ-1A001418, 0631F-01000-00 EJ-1B001511, 0631F-01000-00 EJ-23001764, 0631F-01000-00 EJ-23001768, 0631F-01000-00 EJ-23001769, 0631F-01000-00 EJ-23001779, 0631F-01000-00 EJ-23001792, 0631F-01000-00 EJ-22001696, 0631F-01000-00 EJ-22001701, 0631F-01000-00 EJ-22001705, 0631F-01000-00 EJ-22001707, 0631F-01000-00 EJ-22001723, 0631F-01000-00 EJ-1C001573, 0631F-01000-00 EJ-1C001589, 0631F-01000-00 EJ-1C001590, 0631F-01000-00 EJ-1C001599, 0631F-01000-00 EJ-1C001610, 0631F-01000-00 EJ-1C001619, 0631F-01000-00 EJ-21001667, 0631F-01000-00 EJ-22001679, 0631F-01000-00 EJ-22001686, 0631F-01000-00 EJ-22001688, 0631F-01000-00 EJ-22001721, 0631F-01000-00 EJ-15001187, 0631F-01000-00 EJ-1A001420, 0631F-01000-00 EJ-22001699, 0631F-01000-00 EJ-1B001512, 0631F-01000-00 EJ-1A001459, 0631F-01000-00 EJ-21001635, 0631F-01000-00 EJ-21001636, 0631F-01000-00 EJ-21001637, 0631F-01000-00 EJ-21001658, 0631F-01000-00 EJ-22001681, 0631F-01000-00 EJ-22001692, 0631F-01000-00 EJ-22001693, 0631F-01000-00 EJ-22001698, 0631F-01000-00 EJ-22001700, 0631F-01000-00 EJ-22001703, 0631F-01000-00 EJ-22001712, 0631F-01000-00 EJ-22001734, 0631F-01000-00 EJ-22001741, 0631F-01000-00 EJ-1A001449, 0631F-01000-00 EJ-1A001471, 0631F-01000-00 EJ-1A001478, 0631F-01000-00 EJ-1A001479, 0631F-01000-00 EJ-1A001440, 0631F-01000-00 EJ-1C001585, 0631F-01000-00 EJ-1A001473, 0631F-01000-00 EJ-1A001438, 0631F-01000-00 EJ-1A001442, 0631F-01000-00 EJ-1A001456, 0631F-01000-00 EJ-1A001474, 0631F-01000-00 EJ-1A001463, 0631F-01000-00 EJ-1B001559, 0631F-01000-00 EJ-1B001564, 0631F-01000-00 EJ-1B001496, 0631F-01000-00 EJ-1A001446, 0631F-01000-00 EJ-23001757, 0631F-01000-00 EJ-1A001421, 0631F-01000-00 EJ-1A001424, 0631F-01000-00 EJ-23001753, 0631F-01000-00 EJ-1A001462, 0631F-01000-00 EJ-1A001480, 0631F-01000-00 EJ-1A001484, 0631F-01000-00 EJ-21001657, 0631F-01000-00 EJ-21001662, 0631F-01000-00 EJ-21001670, 0631F-01000-00 EJ-22001675, 0631F-01000-00 EJ-22001676, 0631F-01000-00 EJ-22001689, 0631F-01000-00 EJ-22001694, 0631F-01000-00 EJ-22001697, 0631F-01000-00 EJ-22001702, 0631F-01000-00 EJ-22001708, 0631F-01000-00 EJ-22001713, 0631F-01000-00 EJ-22001716, 0631F-01000-00 EJ-22001717, 0631F-01000-00 EJ-22001718, 0631F-01000-00 EJ-22001720, 0631F-01000-00 EJ-22001722, 0631F-01000-00 EJ-22001727, 0631F-01000-00 EJ-22001736, 0631F-01000-00 EJ-22001740, 0631F-01000-00 EJ-23001762, 0631F-01000-00 EJ-23001778, 0631F-01000-00 EJ-23001783, 0631F-01000-00 EJ-1B001514, 0631F-01000-00 EJ-1B001518, 0631F-01000-00 EJ-1B001523, 0631F-01000-00 EJ-1B001526, 0631F-01000-00 EJ-1C001597, 0631F-01000-00 EJ-1C001606, 0631F-01000-00 EJ-23001750, 0631F-01000-00 EJ-23001767, 0631F-01000-00 EJ-23001772, 0631F-01000-00 EJ-23001777, 0631F-01000-00 EJ-22001732, 0631F-01000-00 EJ-22001745, 0631F-01000-00 EJ-23001766, 0631F-01000-00 EJ-23001773, 0631F-01
Recalling Firm/
Manufacturer
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah NJ 07430
For Additional Information Contact Ms. Diane Arpino
201-995-8407
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
Action 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.
Quantity in Commerce 346 units (311 US - 35 Foreign)
Distribution Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Chile, Colombia, and Venezuela.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = MINDRAY DS USA, INC.
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