Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage:
FDA device recall Z-0518-2014 · posted 2013-12-16 · Terminated
Recall details
- Recalling firm
- Kimberly-Clark Corporation
- Reason for recall
- Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe.
- Action taken
- Kimberly Clark Corporation sent a Product Advisory Notice letter to affected consignees. The letter identified the affected product, problem and actions to be taken. For questions call 770-587-8393 or via email
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 389,300 units
- Distribution
- U.S. Nationwide Distribution
- Date initiated
- 2013-10-24
- Date posted
- 2013-12-16
- Date terminated
- 2017-08-25
- Location
- Roswell, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EPI-SPINAL ANESTHESIA TRAY (K941153) | Preferred Medical Products | 1995-05-30 |