Recall Z-0533-2014 ยท CAZ Anesthesia Conduction Kit
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conju
| Date | Dec 17, 2013 (initiated Oct 28, 2013) |
| Status | Terminated |
| Reason | Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe. |
| Root cause | Component design/selection |
| Action | BD Medical sent a Product Advisory Notice letter dated August 23, 2013 to Iaffected consignees by via traceable courier. The letter identified the affected product, problem and actions to be taken. Distributor have been asked to forward copies of the notification to their customers. For questions call BD Customer Service at 1-888-237-2762. |
| Quantity | 359,250 |
| Distribution | USA Nationwide Distribution and one foreign consignee in Mursalat. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945484 | PIDURAL STEROID SYSTEM Professional Medical Device Consultants, Jun 2, 1995 |