FDA Medical Device Recalls (openFDA)
Kimberly-Clark Corporation: 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
- Recall number
- Z-0518-2014
- Recalling firm
- Kimberly-Clark Corporation
- 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
- Status
- Terminated
- Initiated
- 2013-10-24
- Posted
- 2013-12-16
- Terminated
- 2017-08-25
- 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.
- Root cause
- Component design/selection
- Action
- 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
- Quantity
- 389,300 units
- Distribution
- U.S. Nationwide Distribution
- Lot, serial or model codes
- Lot numbers: 181024, 181129 181217, 181221, 181231, 182022, 182058, 182101, 182108, 182131, 182222, 182223, 182263, 182265, 182289, 182293, 182301, 182315, 181A074, 181A94, 181A154, 181A177, 181A286, 181A289, 181A369, 182A002, 182A005, 182A012, 182A055, 182A056, 182A057, 182A064, 182A074, 182A075/182A78, 182A085, 182090, 182A142, 182AA144, 182A151, 182A155, 182A178, 182A194, 182A196, 182A198, 182A202, 182A204, 182A212, 182A216 and 189A001 (syringe).
- 510(k) numbers
- ["K941153"]
- PMA numbers
- not on file
- Product code
- CAZ
- Firm FEI
- 1000015879
- Firm city
- Roswell
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28