Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapidly determining and c
Check against the official notice below — it lists the full affected range.
Integra LifeSciences is recalling 1,218 units of the Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting (Catalog No. 110-4L) due to potential incorrect assembly. Specifically, the o-ring in the bolt adapter may be positioned incorrectly, which could allow cerebrospinal fluid (CSF) or blood to leak from the bolt adapter. The affected catheters were distributed worldwide, including throughout the United States and internationally to Argentina, Brazil, Bulgaria, Canada, Colombia, Costa Rica, France, Germany, Italy, Mexico, Panama, South Africa, Spain, Switzerland, United Arab Emirates, and the United Kingdom.
The recalled units are identified by the following lot or code numbers: 305000291459, 305000299228, 305000300396, 305000301413, 305000312261, 305000315716, 30500X294240, 30500X304371, 30500X309674, 30500X318076, 3050RX285879, 3050RY297365, 305E00318970, and 305E0X320986. The source document does not specify a remedy or recommended action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is a potential CSF/blood could leak from the bolt adapter.
Reason for recall: Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adapter may be in the wrong location and as a result, there is a potential CSF/blood could leak from the bolt adapter. Distribution: Worldwide Distribution - US (Nationwide) and Internationally to ARGENTINA, BRAZIL, BULGARIA, CANADA, COLUMBIA, COSTA RICA, FRANCE, GERMANY, ITALY, MEXICO, GERMANY, ITALY, MEXICO, PANAMA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED ARAB EMIRATES, AND UNITED KINGDOM Quantity: 1218 units Lot/code info: 305000291459, 305000299228, 305000300396, 305000301413, 305000312261, 305000315716, 30500X294240, 30500X304371, 30500X309674, 30500X318076, 3050RX285879, 3050RY297365, 305E00318970, 305E0X320986
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.