Recall Z-2909-2016— Integra LifeSciences Corp.
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2016-08-23, terminated 2017-03-29. It names one FDA 510(k) clearance: K914995. 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. Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-23
- Terminated
- 2017-03-29
- Firm location
- Plainsboro, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.