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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 Covidiensee related information
Date Initiated by FirmJanuary 22, 2016
Date PostedMarch 21, 2016
Recall Status1 Terminated 3 on June 20, 2017
Recall NumberZ-1213-2016
Recall Event ID 73121
510(K)NumberK030813 K063442 K100603 
Product Classification Catheter, retention type, balloon - Product Code EZL
ProductCovidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes are used to clean the genital area for male and female patients
Code Information Lot Codes: 515358664X 518150564X 522551064X 
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information ContactSAME
203-492-5000
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
ActionMedtronic/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 Commerce7200
DistributionUS (nationwide) and to Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = EZL
510(K)s with Product Code = EZL
510(K)s with Product Code = EZL
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