"***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
FDA Recall Z-1047-201 · Posted 2012-02-16
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Recalling FirmIntegra Neurosciences PR, Inc.
Recall StatusTerminated
Product CodeJXG
Date Initiated2011-11-28
Date Terminated2013-10-29
Product Quantity241 units
Reason for Recall
The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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