GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1087975, M1126445, M1127508, M1

FDA device recall Z-1870-2009 · posted 2009-09-09 · Terminated

Recall details

Recalling firm

GE Medical Systems, LLC

Reason for recall

Breathing circuit inner tube may separate from the rigid connectors under certain conditions. A separation of the inner tube from the connector may prevent adequate gas flow (O2, N2O and anesthetic agents) to the patient. A separation can also cause CO2 re-breathing. This could lead to hypoxia and/or hypercarbia and inadequate anesthesia delivery.

Action taken

GE Healthcare sent consignees 6/5/09 an "Urgent Medical Device Correction" letter dated June 5, 2009. The letter was addressed to Health Care Administrator/Risk Manager; Chief of Anesthesia; Director of Clinical Engineering; Risk Manager. The letter described the Safety Issue, Affected Product Details, Safety Instructions (included "Recall Confirmation" form fax to 973-790-4150), Product Correction and Contact Information.

Root cause

Process control

Status

Terminated

Product code

CAI

Quantity affected

85097

Distribution

Worldwide distribution: USA, AUSTRALIA, DENMARK, FRANCE, ESTONIA, GERMANY, ITALY, JORDAN, NETHERLANDS, NORWAY, SWEDEN, and UNITED ARAB EMIRATES.

Date initiated

2009-06-05

Date posted

2009-09-09

Date terminated

2014-01-16

Location

Waukesha, WI