124 results · 13ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7) CA-45854-P1A; (8) CDA-42703-P1A; AGB+ Quad-Lumen CVC Kit (9) AK-42854-P1A; (10) AK-45854-P1A; AGB+ Two Lumen CVC Kit (11) AK-42802-P1A; (12) AK-45802-P1A; (13) AK-46702-P1A; (14) AK-47702-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Multi-Lumen CVC Kit (15) CDA-45703-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Quad-Lumen CVC Kit (16) CDA-45854-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Two-Lumen CVC Kit (17) CDA-22122-U1A; (18) CDA-42802-P1A; (19) CDA-42854-P1A; (20) CDA-47702-P1A; ARROWg+ard Blue MAC" Two-Lumen CVC Access Kit (21) CDA-21242-1A; ARROWg+ard Blue PSI Kit (22) CDA-29803-1A; ARROWg+ard Blue Two-Lumen CVC Kit (23) AK-22702-P1A; ARROWg+ard Blue You-Bend" Two- Lumen Hemodialysis Catheterization Kit for High Volume Infusions (24) CDA-25122-U1A; Multi-Lumen CVC Kit with Blue FlexTip(R) Catheter and Sharps Safety Features (25) ASK-12703-PRJ; (26) ASK-15703-PRJ; Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (27) ASK-45703-PRH; Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen CVC Kit (28) ASK-45703-PRWJ1; Pressure Injectable ARROWg+ard Blue PLUS(R) Quad-Lumen CVC Kit (29) ASK-42854-PRJ; Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central CVC Kit (30) ASK-47702-PPHP; Pressure Injectable ARROWg+ard Blue PLUS(R)Multi-Lumen CVC Kit (31) ASK-45703-PUCD; Pressure Injectable Multi-Lumen CVC Kit (32) ASK-12703-PCA; (33) ASK-15703-PCA; (34) ASK-15703-PHH; (35) ASK-15703-PLV; Pressure Injectable Multi-Lumen CVC kit with Blue Flex Tip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features (36) ASK-42703-PBM; (37) ASK-15703-PRH; (38) ASK-15703-PRWJ; (39) ASK-42703-PRJ; (40) ASK-45703-PRJ; Pressure Injectable Quad-Lumen CVC Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions (41) ASK-42854-PNMM; Pressure Injectable Two Lumen CVC Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (42) ASK-42802-PBM

FDA Recall
Terminated ·Arrow International Inc·Product code FOZ·December 22, 2017

Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·August 20, 2007

ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A

FDA Recall
Terminated ·Arrow International Inc·Product code FOZ·April 11, 2018

LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.

FDA Recall
Terminated ·Hospira Inc.·Product code MEA·March 8, 2013

Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·October 15, 2015

ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A

FDA Recall
Terminated ·Arrow International Inc·Product code FOZ·April 11, 2018

AC Power Cords, shipped between 06/2005 and 05/2009. These cords were used in the following infusion pump models: Nutrimix, Q-Vue, Q2, Q2 Plus, Ox4, PCA, PCA II, PCA 3, Lifecare PCA, Lifecare 4100, Plum XL 3, Plum XL3M, Plum XL3D, Plum A+/ Plum A+3, and Gemstar Docking Station devices. AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

FDA Recall
Terminated ·Hospira Inc·Product code FRN·August 11, 2009

i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ

FDA Recall
Terminated ·Abbott Point of Care Inc.·Product code GJS·May 5, 2010

BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for Midstream Specimens PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C. For In Vitro Diagnostic Use. Becton Dickinson and Company, Franklin Lakes, NJ.

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JSM·October 12, 2009

LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.

FDA Recall
Terminated ·Hospira Inc.·Product code MEA·March 8, 2013

Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1.

FDA Recall
Terminated ·Cardinal Health 303 dba Cardinal Health·Product code FRN·March 4, 2009

The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.

FDA Recall
Terminated ·Hospira Inc.·Product code MEA·March 8, 2013

BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens; Plus Plastic - Sterile Cup and Tube interiors. Store at 4-25 degrees C. Kit contains Sterile Screw CAP Collection Cup with integrated Transfer Device and 8.0 mL, 16/x100 mm PLUS Plastic Conical Tube for Urinalysis and 4.0 mL 13x75mm Plus Plastic C&C Preservative tube and Castile Soap Towelettes; Becton Dickinson and Company, Franklin Lakes, NJ

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JSM·October 12, 2009

Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The modules are indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous, subcutaneous or epidural. The Alaris Syringe pump and PCA modules can be connected to the Alaris PC unit which is the central programming, monitoring, and power supply component for the Alaris System. The syringe pump and PCA pump uses standard, plastic piston syringes and single-use administration sets with luer-lock connectors.

FDA Recall
Terminated ·CareFusion 303, Inc.·Product code MEA·November 17, 2017

Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.

FDA Recall
Terminated ·Hospira, Inc.·Product code MEA·August 2, 2012

Celesteion PCA-9000A/2 PET/CT System

FDA Recall
Terminated ·Toshiba American Medical Systems Inc·Product code KPS·May 8, 2015

REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265

FDA Recall
Terminated ·Respironics, Inc.·Product code BTT·October 25, 2006

U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe module) (2) Alaris PCA module (Model 8120) (a.k.a. Medley PCA module), CardinalHealth, San Diego, CA 92130

FDA Recall
Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·March 5, 2008

AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

FDA Recall
Terminated ·Avanos Medical, Inc.·Product code FRN·April 24, 2023

Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

FDA Recall
Terminated ·Toshiba American Medical Systems Inc·Product code KPS·April 25, 2016