Ansell Sandel Medical Industries LLC: 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.

Agency Publication Date: January 8, 2014

Affected Products

Product: Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 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.

510 K exempt Device Listing Number D129456 Model Number 2210-N LN 0563 Jan 2016 LN 2263 Jul 2016

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.

510 K exempt Device Listing Number D129456 Model Number 2211-N LN 2782 9/2015 LN 1413 4/2016 LN 1623 5/2016

Product: 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.

510 K exempt Device Listing Number D129456 Model Number 2210-L 1) LN 0662 2/2015 2) LN 2052 6/2015

510 K exempt Device Listing Number D129456 Model Number 2211-L LN 2962

Product: Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 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 A manual surgical scalpel blade for making incisions in various general surgical procedures.

510 K exempt Device Listing Number D129456 Model Number 2215-N LN 1203 and 1553

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

510 K exempt Device Listing Number D129456 Model Number 2215-L LN 2052

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.

510 K exempt Device Listing Number D129456 Model Number 2220-N LN 1793

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67005

Status: Resolved

Manufacturer: Ansell Sandel Medical Industries LLC

Manufactured In: United States

Units Affected: 7 products (50 cases (4800 units); 96 cases (576 units); 15 cases (1440 units); 96 cases (96 units); 96 cases (2880 units); 13 cases (312 units); 24 cases (1176 units); 96 cases (288 units); 1203 - 96 cases (4128 units) ; 1553 -96 cases (3548 units); 96 cases (1920 units); 48 cases (384 units))

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Sources: FDA iRES · Raw API Response

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