ClearanceBrief
510(k) K030813 ยท EZL Catheter, Retention Type, Balloon

PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND

ApplicantPrimary Care Solutions, Inc., Zephyrhills FL, US
DecisionSubstantially Equivalent, May 30, 2003
ReceivedMar 14, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K030813

DateFirm and productCodeLinked 510(k)
Dec 20, 2023Nurse Assist, LLC
0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-B
Open, Classified
NGTNone listed
Dec 20, 2023Nurse Assist, LLC
Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/5163
Open, Classified
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
KOYNone listed
Mar 21, 2016Covidien LLC
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
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
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
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien 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
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover 18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STANDARD
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: PP14SD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
Terminated
EZLNone listed
Mar 21, 2016Covidien LLC
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
Terminated
EZLNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.