Z-0637-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2014
- Initiation Date
- November 12, 2013
- Termination Date
- April 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 cases (312 units); 24 cases (1176 units)
Product Description
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long 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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
510 K exempt Device Listing Number D129456 Model Number 2210-L 1) LN 0662 2/2015 2) LN 2052 6/2015