Integra Ventricular Catheter Accessory Kit recall
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems
Why was Integra Ventricular Catheter Accessory Kit recalled?
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number 951303, Lot #0195786 with expiry 05/2019
- Product
- Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 14
- Distribution
- Nationwide Distribution to KS only
- Recall date
- October 12, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)