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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm January 22, 2016
Date Posted March 21, 2016
Recall Status1 Terminated 3 on June 20, 2017
Recall Number Z-1222-2016
Recall Event ID 73121
510(K)Number K100603  K030813  K063442  
Product Classification Catheter, retention type, balloon - Product Code EZL
Item Code: PP16CSD
Castile soap towelettes are used to clean the genital area for male and female patients
Code Information Lot Codes: 512551264X 515359064X 523657564X 
Recalling Firm/
Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
FDA Determined
Cause 2
Nonconforming Material/Component
Action Medtronic/Covidien notfiied customersl via Federal Express on January 22, 2016,, The letter instructs customers to not use the Castile Soap Towelettes contained in the product kits listed on Attachment 1 and discard the affected towelettes. The Castile Soap packet included in these kits does not impact the integrity of the remaining products in the kit. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878. For questions regarding this recall call 203-492-5000.
Quantity in Commerce 5940
Distribution US (nationwide) and to 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.
510(K) Database 510(K)s with Product Code = EZL and Original Applicant = DEGANIA SILICONE, LTD.
510(K)s with Product Code = EZL and Original Applicant = PRIMARY CARE SOLUTIONS, INC.
510(K)s with Product Code = EZL and Original Applicant = RIVERSTONE RESOURCES SDN. BHD.