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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 Recall
Axillent Debakey Grasping Forceps
see related information
Date Posted December 06, 2013
Recall Status1 Terminated on January 13, 2014
Recall Number Z-0465-2014
Recall Event ID 66823
Premarket Notification
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, Massachusetts 01550-4503
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = KARL STORZ ENDOSCOPY-AMERICA, INC.
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