ClearanceBrief
510(k) K161552 ยท NGT Saline, Vascular Access Flush

0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe

ApplicantBecton, Dickinson and Company, Franklin Lakes NJ, US
DecisionSubstantially Equivalent, Feb 2, 2017
ReceivedJun 6, 2016
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K161552

DateFirm and productCodeLinked 510(k)
Jan 17, 2024Becton Dickinson & Company
PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547
Open, Classified
NGTNone listed
Oct 14, 2019Becton Dickinson & Company
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
Terminated
NGTNone listed
Oct 14, 2019Becton Dickinson & Company
BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
Terminated
NGTNone listed

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