CARE LINE, INC.

FDA registration

CARE LINE, INC.·15 products·🇺🇸 United States

Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: CVC Clear Sequence Change Kit, REF 77070B DIALYSIS Clear Sequence Change Kit, REF 77068B PEDS CVC Clear Sequence Change Kit, REF 77190B PICC Clear Sequence Change Kit, REF 77069B Adult Central Line Dressing Change Kit, REF 74636C Central Line Dressing Kit, VCU, REF 57647B Central Line Removal Kit, REF 78631B Chest Tube Cleaning Kit, REF 73000 CVC Dressing Change Kit, REF 80643D Dressing Change Kit, REF 71538 ED Suture Set, REF 59299C Laceration Kit, REF 59806B Laceration Tray, REF 56957 Laceration Tray, REF 57888B Laceration Tray, REF 59387 Laceration Tray, REF 59387B Laceration Tray, REF 69477B Laceration Tray, REF 71582 LACERATION/SUTURE REMOVAL, REF 72347 LACERATION/SUTURE REMOVAL, REF 72347B Pediatric Central Line Dressing Kit, REF 74635C PICC Central Line Dressing Kit VCU, REF 59589C PICC/CVC/Central /Dialysis Clear Sequence Dressing Kit, REF 78197 Suture Kit, REF 59836 Trach Care Kit, Kit de Traqueostomia, REF LH_68162B Trach Care Tray, REF 56791B Trach Care Tray, REF 75378 Tracheostomy Care Tray, REF 4129 Tracheostomy Tray, REF 80209 Wound Care Kit, REF 68330 Wound Care Tray, REF 68358 MEDICHOICE: Tracheostomy Kit, Reorder: TRAC1002 THERAPY SUPPLY HOUSE: VAD DRESSING CHANGE KIT, Reorder # 76512B

FDA Enforcement

Class II ·Terminated·Medical Action Industries, Inc. 306·January 15, 2020

ACCU-LINE

FDA Adverse Event

Injury ·ACCU-LINE PRODUCTS INC.·Product code FZZ·May 9, 2019

ARTERIAL BLOOD GAS KIT PORTEX LINEDRAW

FDA Adverse Event

Malfunction ·SMITHS MEDICAL ASD, INC·Product code JKA·December 10, 2024

HEPARIN LOCK FLUSH

FDA Adverse Event

Malfunction ·SIERRA PRE-FILLED INC/AM2 PAT·Product code NZW·February 19, 2008

INFUSOMAT®

FDA Adverse Event

Injury ·B. BRAUN MELSUNGEN AG·Product code FRN·September 15, 2023

Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care

FDA Enforcement

Class II ·Terminated·Hospira Inc.·January 9, 2013

Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care

FDA Enforcement

Class II ·Terminated·Hospira Inc.·January 9, 2013

TABLO HEMODIALYSIS SYSTEM

FDA Adverse Event

Injury ·OUTSET MEDICAL, INC.·Product code KDI·February 11, 2026

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event

Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 5, 2021

LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA The Hospira Symbiq Infusion System is a general infusion system which provides IV infusion across the general spectrum of clinical care. The Symbiq pumps are standard sized pumps which are typically facility-based infusion pumps which may be used to deliver continuous and/or intermittent infusions to a variety of patient populations.

FDA Enforcement

Class II ·Terminated·Hospira Inc.·July 24, 2013

ACUNAV DX ULTRASOUND CATHETER

FDA Adverse Event

Malfunction ·STERILMED·Product code OWQ·January 16, 2015

HEMOLUNG RAS

FDA Adverse Event

Death ·ALUNG TECHNOLOGIES, INC.·Product code QOH·January 18, 2023

CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

FDA Enforcement

Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

SUREFORM

FDA Adverse Event

Injury ·INTUITIVE SURGICAL, INC·Product code GDW·July 18, 2025

OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

FDA Enforcement

Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

FDA Adverse Event

Malfunction ·THORATEC CORPORATION·Product code DSQ·June 27, 2024

COVID-19 TEST

FDA Adverse Event

Malfunction ·IHEALTH LABS, INC. / IHEALTH MANUFACTURING INC.·Product code QKP·April 18, 2023

COVID-19 TEST

FDA Adverse Event

Malfunction ·IHEALTH LABS, INC. / IHEALTH MANUFACTURING INC.·Product code QKP·April 18, 2023

HEMOLUNG RAS

FDA Adverse Event

Injury ·ALUNG TECHNOLOGIES, INC.·Product code QOH·January 18, 2023