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U.S. Department of Health and Human Services

Class 2 Device Recall UniCircuit (W Connector, Adaptor, Y piece)

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  Class 2 Device Recall UniCircuit (W Connector, Adaptor, Y piece) see related information
Date Initiated by Firm June 05, 2009
Date Posted September 09, 2009
Recall Status1 Terminated 3 on January 16, 2014
Recall Number Z-1870-2009
Recall Event ID 52605
Product Classification Breathing circuit - Product Code CAI
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.
Code Information This correction pertains to Uni-Circuits from lot# 084812 and later, up to and including lot# 092210
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 85097
Distribution Worldwide distribution: USA, AUSTRALIA, DENMARK, FRANCE, ESTONIA, GERMANY, ITALY, JORDAN, NETHERLANDS, NORWAY, SWEDEN, and UNITED ARAB EMIRATES.
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.
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