Device Recall Integra NeuroSensor 의 리콜

Recall

46788

Class 2

Z-1191-2008

2008-01-28

2008-08-05

Terminated

United States

2010-04-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68272

Incorrect pressure reading: due to a manufacturing error, the icp reading could be inaccurate to the extent that they exceed label claims. specifically, the insertion error label claim of +/- 3mmhg could be exceeded by up to -3mmhg, that could result in a maximum insertion error of +/- 6mmhg.

Integra NeuroSciences sent a Recall Notification with a Recall Acknowledgement form to all customers with product currently in their possession through an Integra Field Sales Repesentative on January 28, 2008. The notification advises that the firm has determined that due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg that could result in a maximum Insertion Error of +/- 6mmHg. Customers are asked to examine their inventory immediately to determine if they have any NeuroSensor Model NS-P's lot #100063 on hand and if so to not use the product. Customers are advised to contact their local Integra representative for further assistance. The letter advises that the lot/serial number is located on a white 1/2" x 1/2" label on the large beige optical connector, and can readily be seen through the bottom of the product tray packaging. The letter also advises that this recall pertains to NeuroSensor Model NS-P's, lot # 100063 -all serial numbers. A response form is included. In addition, the Field Sales Representatives have been instructed to physically remove all lot 100063 of NeuroSensor Probes from inventory and provide replacement product.