Reported Nov 6, 2013 · Terminated
Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B,…
Integra Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra Limited · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Brand NamesIntegra¿ 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 NameIntracranial Pressure and Pressure-Temperature
- Monitoring Kits Classification NameDevice, Monitoring
- Intracranial Pressure 510(k) NumberK102875 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
- Lot codes and dates
Product / Catalogue No.s: 110-4B110-4BC110-4G110-4H110-4HC110-4L110-4LC
- Lot NumbersCatalog
- Number 110-4B
335 of 335 codes
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
- Catalog Number 110-4G
195 of 195 codes
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
- Catalog Number 110-4H
3050RX1982813050RY1941443050RY1982813050RY20086130500X22315430500022094830500022362230500X22538530500X23341730500023171430500024135030500X24387430500025095930500X254932305000263557
- Catalog Number 110-4L
82 of 82 codes
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
- Catalog Number 110-4BC
176044177018178013178898179757180139180955182279182908184079184687185284186277187293190452187780190451191891193414194074195161195608196987197492198189198512200069200490199609201039201595202423203565207077208532
- Catalog Number 110-4HC
179758180956183071184686186278187781190450192246194993195450198191199708201040201596202009
- Catalog Number 110-4LC
162523167450167786175720177188178547182130187495195245197493
- Amount recalled
- 79,887
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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