Recall Z-1870-2009 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
GE Medical Systems, LLC
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. pk
| Date | Sep 9, 2009 (initiated Jun 5, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 85097 |
| Distribution | Worldwide distribution: USA, AUSTRALIA, DENMARK, FRANCE, ESTONIA, GERMANY, ITALY, JORDAN, NETHERLANDS, NORWAY, SWEDEN, and UNITED ARAB EMIRATES. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.