GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1087975, M1126445, M1127508, M1127509, M1129780, M1129781, M1130230, M1137805, M1137199, M1145542, M1170604, M1151662, M1152224, M1158990, M1100486, M1122080, M1126444, M1163003, M1163255 M1132533, M1133966, M1170051, M1135144, M1139485, M1118627, M1118628, M1145406, M1147298, M1137811, M1152651, M1160275. pkg of 20 pcs, Latex Free. Breathing circuit for use with anesthesia machine or ventilator.
FDA Recall Z-1870-2009 · Posted 2009-09-09
Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeCAI
Date Initiated2009-06-05
Date Terminated2014-01-16
Product Quantity85097
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.
Firm Action
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
Distribution Pattern
Worldwide distribution: USA, AUSTRALIA, DENMARK, FRANCE, ESTONIA, GERMANY, ITALY, JORDAN, NETHERLANDS, NORWAY, SWEDEN, and UNITED ARAB EMIRATES.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.