Reported Jan 15, 2014 · Terminated
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured…
Ansell Sandel Medical Industries LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ansell Sandel Medical Industries LLC · 19736 Dearborn St · Chatsworth, CA · 91311-6509
Is this the product you have?
- Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15
- Blade Manufactured forAnsell 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
- Lot codes and dates
- 510 K exempt Device Listing Number D129456 Model Number 2215-L LN 2052
- Amount recalled
- 96 cases (1920 units)
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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