Device product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 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.
Z-0636-2014
Product summary
- Event
- Event 67005
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 cases (1440 units); 96 cases (96 units); 96 cases (2880 units)
- Official record key
device-enforcement:Z-0636-2014
Official wording
Reason: 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.
Code information: 510 K exempt Device Listing Number D129456 Model Number 2211-N LN 2782 9/2015 LN 1413 4/2016 LN 1623 5/2016
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.
Derived failure modes
-
Unknown
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.