Z-1047-201

"REF NL78013-01INTEGRA NEUROSCIENCESStylet for Ventricular CatheterNon Sterile for Single Use...

Name: Z-1047-201 "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use...
Creator: Integra Neurosciences PR, Inc.
Published: 2011-11-28
License: https://open.fda.gov/license/

Integra NeuroSciences / initiated 2011-11-28 / Terminated / root cause: labeling and UDI

FDA source

Integra Neurosciences PR, Inc. began a recall of "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro... on 2011-11-28. The reason FDA records is "The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1047-201
Status: Terminated
Initiated: 2011-11-28
Posted: 2012-02-16
Terminated: 2013-10-29
Recalling firm: Integra NeuroSciences
Product: "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***" Stainless steel stylet for ventricular catheter
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or [email protected] For questions call 609-936-2495.
Quantity in commerce: 241 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
Product codes and lots: 1010344, 1011451, 1021637, 1030061, 1032742, 1040738, 1041561, 1052595, 1053121, 1053487, 1080115, 1080148, 1081155, 1082137

Product code JXG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)