Anesthesia device service kits. ASSY-MSN recall
Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY…
Why was Anesthesia device service kits. ASSY-MSN recalled?
The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
11328664 11335735 11343334 11343892 11342401-2 5400168 5403740-1 5403740-2 11335499 11345497 11340364 11320301-1 11320301-2 11330567 11331744 11307341 11331786 11335845 11335293 11319820 11321192 11321193 11327291 11322915 11332821 11326031 11330266 11313876 11331340 11304929 11336322 11336553 11315455 11325139 11326345 11335028-1 11335028-2 11305735 11322211 11323901 6514379 6514380 11307579 11307579 11321258 5398226 5405405 11337945 5404884 5405628 5406602 5401553-1 5401553-2 5402221-1 5402221-2 5402221-3 5404056-1 5404056-2 5404550-1 5404550-2 5404550-3 5404550-4 5405413-1 5405413-2 5405413-3 5405699-1 5405699-2 5405699-3 11009279 5405867 5405868 5398018-1 5398018-2 5404050-1 5404050-2 5405504-1 5405504-2 11320017 11324236 11311155 11342043 5401539 5401527-1 5401527-2 5401527-3 5401527-4 11315668 5401531 11334842 11305495 11333980 11339911 11330029-2 11308028 11323566 11323905 5406531 11334842 11305495 11333980 11339911 11330029-2 11308028 11323566 11323905 5406531
- Product
- Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY…
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 240
- Distribution
- Worldwide Distribution - US (nationwide including PR except NH, VT, & WY. Internationally to ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, CHANA, GIBRALTAR, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA,MALAYSIA, MALDIVES, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI lanka, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.
- Recall date
- January 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)