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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

Vyaire Medical ventilators - recalled due technical failure alarm, USA

4 years ago •source fda.gov • details

Imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305. There is a potential issue with bellavista™ 1000 and 1000e ventilators that… See more

#recall #medicaldevices #unitedstates

Recalls Vyaire Medical ventilators - recalled due technical failure alarm Imtmedical ag, a subsidiary of Vya... photo #1
312   Comments Comment

Recall notice

Oscor Destino Twist & Guidestar - recalled due to potential detachment, USA

4 years ago •source fda.gov • details

Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal… See more

#recall #medicaldevices #unitedstates

Recalls Oscor Destino Twist & Guidestar - recalled due to potential detachment Oscor Inc. is voluntarily rec... photo #1
312   Comments Comment

Recall notice

Cardinal Health’s Monoject™ Prefilled Syringes - recalled due to potential air draw back, USA

4 years ago •source fda.gov • details

On August 19, 2021, Aligned Medical Solutions initiated a nationwide recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes placed into 9,378 kits. Including:
- 1 lot of AMS-9041CP Leaderflex Insertion Kit with Ultrasound
- 1 lot of AMS-9046CP-1 Insertion Tray-RX
- 45 lots of AMS8939A Universal… See more

#recall #medicaldevices #unitedstates

Recalls Cardinal Health’s Monoject™ Prefilled Syringes - recalled due to potential air draw back On August 1... photo #1
312   Comments Comment

Recall notice

Cook Medical Transseptal Needle and Transseptal Needle Catheter - recalled due to Complaints of rust on the products, USA

4 years ago •source fda.gov • details

Company name: Cook Medical
Brand name: Cook Medical
Product recalled: Transseptal Needle and Transseptal Needle Catheter
Reason of the recall: Complaints of rust on the products
FDA Recall date: October 19, 2021
Recall details: Bloomington, Ind. — On October 8, 2021, Cook Medical issued a global, voluntary… See more

#recall #medicaldevices #unitedstates

Recalls Cook Medical Transseptal Needle and Transseptal Needle Catheter - recalled due to Complaints of rust... photo #1
312   Comments Comment

Recall notice

LeadCare® Test Kits - recalled due to underestimated blood lead levels, USA

4 years ago •source fda.gov • details

Company name: Meridian Bioscience, Inc.
Brand name: Meridian Bioscience, Inc.
Product recalled: LeadCare® Test Kits
Reason of the recall: LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples
FDA Recall date: September 02, 2021
Recall details: Meridian Bioscience, Inc. (NASDAQ: VIVO),… See more

#blood #recall #medicaldevices #unitedstates

312   Comments Comment

Recall notice

Spectrum IQ Infusion Pumps - recalled due to Multiple Connectivity Errors, USA

4 years ago •source fda.gov • details

Company name: Baxter International Inc.
Brand name: Spectrum IQ
Product recalled: Infusion Pumps
Reason of the recall: Multiple Connectivity Errors
FDA Recall date: August 24, 2021
Recall details: Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for all Spectrum IQ infusion pumps… See more

#medicaldevices #recall #unitedstates

312   Comments Comment

Recall notice

Monoject Flush Prefilled Saline Syringes - recalled due to air reintroducing into the syringe, USA

4 years ago •source fda.gov • details

Company name: Cardinal Health
Brand name: Monoject
Product recalled: Flush Prefilled Saline Syringes
Reason of the recall: Products have been found to reintroduce air into the syringe after the air has been expelled
FDA Recall date: August 20, 2021
Recall details: On August 4, 2021, Cardinal Health… See more

#blood #recall #medicaldevices #unitedstates

Recalls Monoject Flush Prefilled Saline Syringes - recalled due to air reintroducing into the syringe Compan... photo #1
312   Comments Comment

Recall notice

Ultrasound Gel - recalled due to product is contaminated with bacteria, USA

4 years ago •source fda.gov • details

Company name: Eco-Med Pharmaceutical
Brand name: Multiple brand names
Product recalled: Ultrasound Gel
Reason of the recall: Product is contaminated with bacteria (Burkholderia cepacia complex)
FDA Recall date: August 04, 2021
Recall details: Etobicoke, Ontario (August 4, 2021) – Eco-Med Pharmaceuticals, Inc. today commenced a voluntary recall… See more

#recall #medicaldevices #unitedstates

312   Comments Comment

Recall notice

BD Alaris System - recalled due to Infusion pump may not operate as expected, USA

4 years ago •source fda.gov • details

Company name: Becton, Dickinson and Company
Brand name: BD
Product recalled: Alaris System
Reason of the recall: Infusion pump may not operate as expected
FDA Recall date: August 02, 2021
Recall details: FRANKLIN LAKES, N.J., July 29, 2021 /PRNewswire/ BD (Becton, Dickinson and Company) (NYSE: BDX), a… See more

#blood #recall #medicaldevices #unitedstates

312   Comments Comment

Recall notice

Hypodermic Needle Insulin Syringes - recalled due to skewed markings on syringes, USA

4 years ago •source fda.gov • details

Company name: Smiths Medical
Brand name: Jelco
Product recalled: Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Reason of the recall: Skewed odd number line graduation markings on syringe barrels.
FDA Recall date: June 17, 2021
Recall details: Company Announcement Smiths Medical has become aware of specific models and… See more

#recall #medicaldevices #unitedstates

312   Comments Comment

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