Recall Z-0641-2014— Ansell Sandel Medical Industries LLC
Class II · Terminated
Class II FDA medical device recall by Ansell Sandel Medical Industries LLC, initiated 2013-11-12, terminated 2016-04-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 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: 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..
- Recalling firm
- Ansell Sandel Medical Industries LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-12
- Terminated
- 2016-04-06
- Firm location
- Chatsworth, CA, United States
Product description
Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.