FDAFDA · Food and drugs·Recall number Z-0637-2014
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.
Published January 15, 2014 · Recall initiated: November 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ansell Sandel Medical Industries LLC
- Distributor
- 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.
- Lot
- 510 K exempt Device Listing Number D129456 Model Number 2210-L 1) LN 0662 2/2015 2) LN 2052 6/2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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