Recall Z-2906-2016
Integra LifeSciences Corp. · initiated August 23, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes
Codes / lots: Catalog Number F75221, Lot #0195486 with expiry 04/2021
Reason for recall
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
FDA-determined cause: Process control
Action taken
Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
Details
- Recall number
- Z-2906-2016
- Initiated
- August 23, 2016
- Terminated
- March 29, 2017
- Product code
- JXG – Shunt, Central Nervous System And Components
- Quantity
- 9
- Distribution
- Nationwide Distribution to KS only
- Recalling firm
- Integra LifeSciences Corp., Plainsboro, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2905-2016 Class II | Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | 08/23/2016Terminated |
| Z-2907-2016 Class II | Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | 08/23/2016Terminated |
| Z-2908-2016 Class II | Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | 08/23/2016Terminated |
| Z-2909-2016 Class II | Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | 08/23/2016Terminated |
| Z-2910-2016 Class II | Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC…During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of… | 08/23/2016Terminated |