Date Initiated by Firm | January 22, 2016 |
Date Posted | March 21, 2016 |
Recall Status1 |
Terminated 3 on June 20, 2017 |
Recall Number | Z-1210-2016 |
Recall Event ID |
73121 |
510(K)Number | K030813 K063442 K100603 |
Product Classification |
Catheter, retention type, balloon - Product Code EZL
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Product | Covidien Dover P400 PREM U/M 16FR TMP SNS CSD
Item Code: P4P16TSD
Castile soap towelettes are used to clean the genital area for male and female patients |
Code Information |
Lot Codes: 520858164X 525756164X |
Recalling Firm/ Manufacturer |
Covidien LLC 60 Middletown Ave North Haven CT 06473-3908
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For Additional Information Contact | SAME 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 |
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 | 7200 |
Distribution | US (nationwide) and to Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = EZL 510(K)s with Product Code = EZL 510(K)s with Product Code = EZL
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