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Terminated

Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap towelettes are used to clean the genital area for male and female patients

FDA Recall Z-1205-2016 · Posted 2016-03-21

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeEZL
Date Initiated2016-01-22
Date Terminated2017-06-20
Product Quantity3000

Reason for Recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US (nationwide) and to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063442ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSORDegania Silicone , Ltd. · 2007-03-26K030813PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 ANDPrimary Care Solutions, Inc. · 2003-05-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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