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AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.

FDA Recall
Terminated ·Fenwal Inc·Product code LKN·May 24, 2013

Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

FDA Recall
Terminated ·Baxter Healthcare Corp.·Product code KDJ·October 6, 2015

GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code FER·December 12, 2018

Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N

FDA Recall
Terminated ·Atrium Medical Corporation·Product code CAC·November 8, 2006

PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.

FDA Recall
Terminated ·Microport Orthopedics INC.·Product code LXH·April 30, 2014

L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

FDA Recall
Terminated ·Baxter Healthcare Corporation·Product code FKX·October 10, 2018

Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3, Manufactured for Baxa Corporation.

FDA Recall
Terminated ·Baxa Corporation·Product code KPE·May 26, 2010

Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.

FDA Recall
Terminated ·Baxter Healthcare Corporation·Product code KPE·July 27, 2017

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·June 12, 2018

Flat Proximal Pressurizer. Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code KIH·January 13, 2012

ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.

FDA Recall
Terminated ·AGFA Corp.·Product code KPR·November 18, 2005

Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL, Order No. REF 706, Baxa Corporation.

FDA Recall
Terminated ·Baxa Corporation·Product code KPE·May 26, 2010

SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2

FDA Recall
Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023

SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S

FDA Recall
Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023

SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

FDA Recall
Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023

AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

FDA Recall
Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

FDA Recall
Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code GWJ·November 6, 2025

Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile and non-pyrogenic in unopened, undamaged package, 250 mL, Order No. REF: 706D, Baxa Corporation.

FDA Recall
Terminated ·Baxa Corporation·Product code KPE·May 26, 2010

Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code CGJ·November 5, 2012

MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

FDA Recall
Terminated ·ConMed Corporation·Product code GEI·May 8, 2014