ClearanceBrief
510(k) K032438 ยท NGT Saline, Vascular Access Flush

MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE

ApplicantTyco Healthcare, Mansfield MA, US
DecisionSubstantially Equivalent, Jun 30, 2004
ReceivedAug 7, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K032438

DateFirm and productCodeLinked 510(k)
Aug 19, 2021Windstone Medical Packaging, Inc.
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultras
Open, Classified		 NGTNone listed
Aug 4, 2021Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling in
Open, Classified		 NGTNone listed
Aug 4, 2021Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling int
Open, Classified		 NGTNone listed
Aug 4, 2021Cardinal Health
Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intr
Open, Classified		 NGTNone listed
Sep 10, 2013Covidien LLC
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syr
Terminated		 NGTNone listed
Sep 10, 2013Covidien LLC
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syri
Terminated		 NGTNone listed
Sep 10, 2013Covidien LLC
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Product ID: 8881570125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syri
Terminated		 NGTNone listed
Sep 10, 2013Covidien LLC
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes
Terminated		 NGTNone listed
Sep 10, 2013Covidien LLC
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes
Terminated		 NGTNone listed
Sep 10, 2013Covidien LLC
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes
Terminated		 NGTNone listed
Sep 10, 2013Covidien LLC
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syring
Terminated		 NGTNone listed
Sep 10, 2013Covidien LLC
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringe
Terminated		 NGTNone listed
Sep 10, 2013Covidien LLC
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syring
Terminated		 NGTNone listed
Dec 9, 2010Covidien LP
MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 10 ml in 12 ml syringe Item code 8881580121
Terminated		 NGTNone listed
Dec 9, 2010Covidien LP
MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item code 8881580123
Terminated		 NGTNone listed
Dec 9, 2010Covidien LP
MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 5 ml in 12 ml syringe Item code 8881580125
Terminated		 NGTNone listed
Dec 9, 2010Covidien LP
MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 10 ml in 12 ml syringe Item code 8881590121
Terminated		 NGTNone listed
Dec 9, 2010Covidien LP
MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 3 ml in 12 ml syringe Item code 8881590123
Terminated		 NGTNone listed
Dec 9, 2010Covidien LP
MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 5 ml in 12 ml syringe Item code 8881590125
Terminated		 NGTNone listed
May 9, 2008Covidien LP
Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123, Tyco Healthcare, Mansfield, MA 02048
Terminated		 NZWNone listed
May 9, 2008Covidien LP
Tyco Healthcare Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL REF # 8881580125Tyco Healthcare, Mansfield, MA 02048
Terminated		 NZWNone listed
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 2.5mL in 3mL syringe REF # 8881580300, Tyco Healthcare, Mansfield, MA 02048
Terminated		 NZWNone listed
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881581125, Tyco Healthcare, Mansfield, MA 02048
Terminated		 NZWNone listed
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 10mL REF # 8881590121, Tyco Healthcare, Mansfield, MA 02048
Terminated		 NZWNone listed
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL REF # 8881590123, Tyco Healthcare, Mansfield, MA 02048
Terminated		 NZWNone listed
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 100UlmL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881591125, Tyco Healthcare, Mansfield, MA 02048
Terminated		 NZWNone listed

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