Recall Z-2588-2010 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Integra LifeSciences Corp.
Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; Sterile, Rx only. Manufactured by Integra NeuroSciences Implants S.A., Sophia Antipolis Cedex, France; distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538; This product is distributed by Integra NeuroSciences under catalog number 910-500 and in Suction Valve Reservoir Kits unde
| Date | Sep 28, 2010 (initiated May 7, 2010) |
| Status | Terminated |
| Reason | The sterility of the product may be compromised. Integra LifeSciences Corp. received a recall notification from Saint-Gobain Performance Plastics, France, contract manufacturer of the Integra Suction Reservoir with Anti-Reflux Valve, that the product's sterility may be affected by a sterilization issue discovered by the supplier. |
| Root cause | Other |
| Action | Integra sent Urgent Product Recall letters dated May 7, 2010 to customers identifying the affected product, the sterility issue, and actions to be taken by the customer. Customers are instructed to quarantine and return all affected inventory to Integra's distribution center in Sparks, NV, using a Returned Material Authorization Number received from Integra LIfeSciences Customer Service at 800 654-2873. All Customers are requested to return the attached "Recall Acknowledgement. and Return Form" Integra LIfeSciences can be contacted at 609-936-2495. |
| Quantity | 313 units |
| Distribution | Worldwide Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NC, NH, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WI, and the countries of Australia, Chile, Costa Rica, and Sri Lanka. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.