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U.S. Department of Health and Human Services

Class 2 Device Recall Axillent Debakey Grasping Forceps

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  Class 2 Device Recall Axillent Debakey Grasping Forceps see related information
Date Initiated by Firm November 06, 2013
Date Posted December 06, 2013
Recall Status1 Terminated 3 on January 13, 2014
Recall Number Z-0465-2014
Recall Event ID 66823
510(K)Number K934937  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Axillent Debakey Grasping Forceps, Part No. 33821DYD

In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
Code Information Lot Code YX
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy America Inc
15 Wells St
Southbridge MA 01550-4503
For Additional Information Contact
746-708-8440
Manufacturer Reason
for Recall		 KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.
FDA Determined
Cause 2		 Labeling mix-ups
Action Karl Storz Endosocopy sent a Safety Alert letter dated November 6, 2013, to all customers who received the 33821DYD Axillent Debakey Grasping Forceps. The letter informed the customers of the problems identified and the actions to be taken. Customers were asked to set aside the mislabeled product and return the mislabeled instruments with the RMA (Return Material Authorization) number issued to them. Customers were instructed to fax or email completed recall response form to (424) 218-8519. Customers with any questions were instructed to call (800) 421-0837 ext 8289. For questions regarding this recall call 746-708-8440.
Quantity in Commerce 7 units
Distribution Nationwide Distribution including states of: TX, PA, and NY.
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.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = KARL STORZ ENDOSCOPY-AMERICA, INC.
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