—#83446

Product

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 product code: CAI — Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: This correction pertains to Uni-Circuits from lot# 084812 and later, up to and including lot# 092210

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2009-06-05
Posted by FDA: 2009-09-09
Terminated: 2014-01-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83446. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.