Recall Z-1229-2016— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2016-01-22, terminated 2017-06-20. It names 4 FDA 510(k) clearances: K100603, K063442, K030813 and 1 more. Product: Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients. Reason: Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria.
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-22
- Terminated
- 2017-06-20
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
4 on FDA's record- K100603 — RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
- K063442 — ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
- K030813 — PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND
- K833790 — CURITY 100% SILICONE COUDE' CATHETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients
Reason for recall
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
Data sourced from openFDA. This site is unofficial and independent of the FDA.