Brand Names: Integra¿ Camino 110-4 Intracranial Pressure — Class II medical device recall Z-0117-2014
Terminated recall by Integra Limited, reported 2013-11-06, distributed nationwide. Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA require
| Recall number | Z-0117-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra Limited, Plainsboro, NJ, United States |
| Recall initiated | 2013-09-10 |
| Classified | 2013-10-30 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2014-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 79,887 |
| UPC / GTIN / UDI-DI | 00305000207061, 00305000207580, 00305000211419, 00305000211723, 00305000219118, 00305000219989, 00305000221227, 00305000226871, 00305000228523, 00305000229827, 00305000230304, 00305000231462, 00305000231714, 00305000232605, 00305000233244, 00305000238263, 00305000238539, 00305000242796, 00305000250456, 00305000251453, 00305000253785, 00305000254591, 00305000262978, 00305000267423, 00305000272274 |
| Model numbers | 110, 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC, 162523, 167450, 167786, 175720, 176044, 177018, 177188, 178013, 178547, 178898, 179757, 179758, 180139, 180955, 180956, 182130, 182279 and 475 more |
Product
Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox¿ Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.
Reason for recall
Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino¿ Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR environment. Only the following Camino¿ Intracranial Pressure Monitoring Kits are affected: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0117-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.