Recall Z-0812-2014 ยท CAH Filter, Bacterial, Breathing-Circuit
Vital Signs Colorado Inc.
Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.
| Date | Jan 23, 2014 (initiated Dec 26, 2013) |
| Status | Terminated |
| Reason | A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow. |
| Root cause | Process control |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter on December 12, 2013 to all affected customers via certified letter to follow the safety instructions to: 1) Please follow all safety instructions in accordance with the instructions for use (IFU). 2) During installation, visually inspect the Vital Signs Breathing Circuits for any plugged ports. If 15mm or 22mm blue port caps are attached to any ports, please remove and discard. 3) Prior to use, the circuits should be pressure tested for leaks and flow tested for obstructions in accordance with the ventilator manufacturers specifica |
| Quantity | 1,827,920 units US , 504,760 units OUS |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico; and Internationally to: Belgium, Canada, Chile, Mexico, Costa Rica, Kuwait, United Kingdom, Greece, Czech Republic, Latvia, Turkey, China, France, Italy, Brazil, Korea, Germany, Thailand, Egypt, Austria, Dominican Republic, India, Isra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831856 | BREATHING CIRCUIT BACTERIA FILTER Vital Signs, Inc., Sep 26, 1983 |