Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra k
FDA device recall Z-0533-2014 · posted 2013-12-17 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 359,250
- Distribution
- USA Nationwide Distribution and one foreign consignee in Mursalat.
- Date initiated
- 2013-10-28
- Date posted
- 2013-12-17
- Date terminated
- 2014-01-29
- Location
- Salt Lake City, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PIDURAL STEROID SYSTEM (K945484) | Professional Medical Device Consultants | 1995-06-02 |