Westmed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
24
510(k) Clearances
8
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0263-2025Class II1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mmSeptember 27, 2024
Z-0745-2021Class IIREF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source toNovember 11, 2020
Z-0746-2021Class IIREF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer ConnecNovember 11, 2020
Z-0742-2021Class IIWestmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709November 11, 2020
Z-0744-2021Class IIREF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7'November 11, 2020
Z-0741-2021Class IIREF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)November 11, 2020
Z-0743-2021Class IIREF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .10November 11, 2020
Z-2436-2020Class IINeo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible InfaJanuary 15, 2019
Z-2435-2020Class IINeo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible InfantJanuary 15, 2019
Z-2434-2020Class IINeo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15January 15, 2019
Z-0105-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1" A NeedlJanuary 18, 2011
Z-0108-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A Needle w/EclipseJanuary 18, 2011
Z-0102-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1", 25U BaJanuary 18, 2011
Z-0103-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A NJanuary 18, 2011
Z-0098-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U BJanuary 18, 2011
Z-0099-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" AJanuary 18, 2011
Z-0101-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A NJanuary 18, 2011
Z-0096-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" AJanuary 18, 2011
Z-0100-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g x 1" A NJanuary 18, 2011
Z-0107-2013Class IIPulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A NeedlJanuary 18, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K162343Westmed Gas Sampling Cannula with O2 deliveryDecember 14, 2016
K143148Disposable Pressure Manometer (DPM)August 11, 2015
K133057VIBRALUNG ACOUSTICAL PERCUSSORMay 23, 2014
K121382WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]December 6, 2012
K081905ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMPJuly 15, 2008
K072220PEDI CO2 EASYAugust 23, 2007
K070128CO2 EASYFebruary 15, 2007
K953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKSeptember 18, 1995