Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
Enforcement
- Recall Number
- Z-0635-2014
- Event ID
- 67005
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ansell Sandel Medical Industries LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 15, 2014
- Initiation Date
- November 12, 2013
- Classification Date
- January 7, 2014
- Termination Date
- April 6, 2016
- Address
- 19736 Dearborn St, Chatsworth, CA, 91311-6509, United States
Description
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China Packaged in Mexico Ansell A manual surgical scalpel blade for making incisions in various general surgical procedures.
Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
510 K exempt Device Listing Number D129456 Model Number 2210-N LN 0563 Jan 2016 LN 2263 Jul 2016
Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.
50 cases (4800 units); 96 cases (576 units)