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U.S. Department of Health and Human Services

Class 2 Device Recall Ansell Sandel Weighted Safety Scalpel

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  Class 2 Device Recall Ansell Sandel Weighted Safety Scalpel see related information
Date Initiated by Firm November 12, 2013
Date Posted January 08, 2014
Recall Status1 Terminated 3 on April 06, 2016
Recall Number Z-0636-2014
Recall Event ID 67005
Product Classification Handle, scalpel - Product Code GDZ
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.
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 
Recalling Firm/
Manufacturer		 Ansell Sandel Medical Industries LLC
19736 Dearborn St
Chatsworth CA 91311-6509
For Additional Information Contact
866-764-3327 Ext. 556
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Ansell, sent an "URGENT: VOLUNTARY RECALL OF ANSELL SANDEL WEIGHTED SAFET SCALPEL" letter dated November 11, 2013 to its customers and posted a website notification on November 11, 2013. The letter described the product, problem and actions to be taken. The customers were instructed: Do not ship SANDEL Weighted Safety Scalpel products 2210-L, 2210-N, 2211-L, 2211-N, 2215-L, 2215-N, or 2220-N to a hospital or end user with the listed lot numbers; quarantine SANDEL Weighted Safety Scalpel products in your inventory; and complete the attached response form and return it to attention: Ansell; via fax at 818-534-2510 or email sandel-cs@ansell.com. Additionally, if you have distributed this product to other accounts, please notify them of the voluntary recall and instruct them to return any outstanding stock to you as indicated in the attachment. If you have any questions or need additional information, please contact Customer Service by calling 866-764-3327 (6:00am-5:00pm PST/9:00am-8pm EST) or email sandel-cs@ansell.com
Quantity in Commerce 15 cases (1440 units); 96 cases (96 units); 96 cases (2880 units)
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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