Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 11
FDA device recall Z-0117-2014 · posted 2013-10-30 · Terminated
Recall details
- Recalling firm
- Integra Limited
- 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.
- Action taken
- Integra sent an Urgent Medical Device Correction Field Safety Notice dted September 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and determine if they have any of the affected product. If so, customers were asked to ensure that the information contained in the letter be distributed to the appropriate personnel. Complete the attached form return it by email or fax as indicated on the form. Customers with questions were instructed to contact Customer Service at 1-855-532-1723. For questions regarding this recall call 1-800-997-4868, outside of the US 888-980-7742.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 79,887
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-09-10
- Date posted
- 2013-10-30
- Date terminated
- 2014-06-04
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C (K102875) | Integra LifeSciences Corporation | 2010-12-20 |