Recall Z-0518-2014— Kimberly-Clark Corporation
Class II · Terminated
Class II FDA medical device recall by Kimberly-Clark Corporation, initiated 2013-10-24, terminated 2017-08-25. It names one FDA 510(k) clearance: K941153. Product: Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs. Reason: 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..
- Recalling firm
- Kimberly-Clark Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-24
- Terminated
- 2017-08-25
- Firm location
- Roswell, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.