ClearanceBrief
510(k) K965017 ยท CAZ Anesthesia Conduction Kit

REGIONAL ANESTHESIA TRAYS

ApplicantSmiths Industries Medical Systems, Inc., Keene NH, US
DecisionUnknown, Mar 14, 1997
ReceivedDec 16, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K965017

DateFirm and productCodeLinked 510(k)
Jan 15, 2026ICU Medical Inc.
Portex Spinal Tray, Item No. A3729-24 A3595
Open, Classified
CAZNone listed
Nov 22, 2006Smiths Medical ASD, Inc.
Portex Continuous Epidural tray Ref 4948-17
Terminated
CAZNone listed
Nov 30, 2005Smiths Medical ASD, Inc.
4902 Glass L.O.R. Syringe
Terminated
CAZNone listed
Nov 30, 2005Smiths Medical ASD, Inc.
4903 Glass L.O.R. Syringe
Terminated
CAZNone listed
Nov 30, 2005Smiths Medical ASD, Inc.
4904 Glass L.O.R. Syringe
Terminated
CAZNone listed
Nov 30, 2005Smiths Medical ASD, Inc.
4950-16 Portex Epidural Mini-pack
Terminated
CAZNone listed
Nov 27, 2003Portex Inc
Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20
Terminated
CAZNone listed

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