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U.S. Department of Health and Human Services

Class 3 Device Recall Staple Remover Kit

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  Class 3 Device Recall Staple Remover Kit see related information
Date Initiated by Firm April 12, 2013
Date Posted May 11, 2013
Recall Status1 Terminated 3 on June 02, 2015
Recall Number Z-1304-2013
Recall Event ID 64908
510(K)Number K761193  
Product Classification Kit, surgical instrument, disposable - Product Code KDD
Product Curity Staple Remover Kit; Product Code: 66701.

Staple Remover Kit.
Code Information 103387264, 117881264, 110983964, 214981164, 117488864
Recalling Firm/
Manufacturer		 Covidien LLC
15 Hampshire Street
Mansfield MA 02048-1113
For Additional Information Contact Jim Welsh
508-261-8000
Manufacturer Reason
for Recall		 On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.
FDA Determined
Cause 2		 Error in labeling
Action US Customers were notified of the recall by letter sent by Federal Express on April 12, 2013. The letter requests that they immediately stop using any affected product, quarantine it, and return it to Covidien. Consignees were asked to return a verification form and return it to Covidien via fax.
Quantity in Commerce 52363 distributed
Distribution Worldwide distribution: USA (nationwide) and in the country of: Panama.
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 = KDD and Original Applicant = SUPERIOR PLASTIC PRODUCTS CORP.
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