Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and Integra NeuroSciences Ventrix Ve
FDA device recall Z-2053-2009 · posted 2009-09-08 · Terminated
Recall details
- Recalling firm
- Integra Neuro Sciences
- Reason for recall
- Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip.
- Action taken
- An "Urgent-Product Recall Notification" letter dated March 23, 2009 was issued to consignees. The letter described the issue and instructed customers to examine their inventory immediately to determine whether they have any NL950V - Ventrix Ventricular Tunneling Pressure Monitoring Kits, or NL950VC - Ventrix Ventricular Tunneling Pressure Monitoring Kits with Ventricular Drainage System. Customers were further instructed not to use the above recalled product. Call Integra Customer Service at 1-800-654-2873, and then select 5 for 'Returns and Repairs' to obtain a Returned Material Authorization number, and return the product as directed. Direct questions about the recall to Integra NeuroSciences by calling 1-858-455-1115, extension185.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 274 kits
- Distribution
- Worldwide Distribution -- US (states of AR, CA, OH, TX, CT, NY, LA, FL, NY, IL, and VA), Belgium and Malaysia.
- Date initiated
- 2009-03-16
- Date posted
- 2009-09-08
- Date terminated
- 2012-07-19
- Location
- San Diego, CA
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