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    HeartStart FR2+ Defibrillator

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·December 19, 2006

    HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·September 22, 2010

    HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no configurable manual charge. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·September 22, 2010

    HeartStart FR2+ AED with Text Display (No ECG), Model 3841, Laerdal brand, no configurable manual charge. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·September 22, 2010

    HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual charge in advance mode. The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·September 22, 2010

    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04

    FDA Recall
    Open, Classified ·Stryker Orthopaedics·Product code OLO·April 15, 2024

    EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·January 15, 2020

    Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A

    FDA Recall
    Open, Classified ·Philips North America LLC·Product code MKJ·February 9, 2021

    HeartStart FR2+ AED with Text Display, Model 989803148611. This product is G2005 Update in accordance with the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (ECC). The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·September 22, 2010

    HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update according to the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (ECC). The label of the device states: "HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121".

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·September 22, 2010

    Philips HeartStart FR2+ Defibrillator Automated External Defibrillator (AED) Catalog Numbers: M3860A/M3861A/M3840A/M3841A

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·February 28, 2007

    HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG on screen; configurable manual charge in advance mode.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·May 28, 2010

    HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand; configurable ECG on screen; configurable manual charge in advance mode.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·May 28, 2010

    The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code MDS·July 15, 2020

    HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·May 28, 2010

    HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·May 28, 2010

    MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYNC1816, 15 Fr; 2. DYND10350, 15 Fr.

    FDA Recall
    Open, Classified ·Product code OHR·May 4, 2026

    Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQY·June 17, 2009

    Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG Module. M3860A is under the Philips label and M3840A is under the Laerdal label.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code MKJ·October 1, 2009

    Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-07155-UPM

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OES·April 21, 2026