Device product
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 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 2215-L Weighted Safety Scalpel, #3L Handle (8.75) with #15 Blade, Yellow Shield with TIME OUT¿ Sleeve (S) 12 per box; 8 boxes per case (96 total scalpels) A manual surgical scalpel blade for making incisions in various general surgical procedures.
Z-0640-2014
Product summary
- Event
- Event 67005
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96 cases (1920 units)
- Official record key
device-enforcement:Z-0640-2014
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 2215-L LN 2052
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.