Drugs & medicalClass II

Natus Medical Incorporated recalls EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Read the official notice →
Date
2024-01-10
Country
United States
Brand
Natus Medical
Product
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Classification
Class II
Units
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Natus Medical recalls

  1. 2022-12-28
  2. US
    Drugs & medicalClass II

    Natus Medical Incorporated recalls The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to…

    Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and…

    FDA · DeviceNatus Medical IncorporatedU.S. Nationwide distribution in the states of AK, CA, CT, DC, FL, GA, IA, ID,…Official notice →
All 2 Natus Medical recalls →

Other drugs & medical recalls in the United States

  1. 2024-01-10
  2. US
    Drugs & medicalClass II

    Zimmer Biomet Spine Inc. recalls Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System

    Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw…

    FDA · DeviceZimmer Biomet Spine Inc.US Nationwide distribution in the states of MN, NE.Official notice →
  3. US
    Drugs & medicalClass II

    Philips Respironics, Inc. recalls Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B…

    The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10…

    FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL,…Official notice →
  4. US
    Drugs & medicalClass II

    Abiomed, Inc. recalls Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella…

    The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature;…

    FDA · DeviceAbiomed, Inc.Domestic distribution nationwide.Official notice →
  5. US
    Drugs & medicalClass II

    Beaver Visitec International, Inc. recalls Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025

    One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.

    FDA · DeviceBeaver Visitec International, Inc.International Distribution to Japan.Official notice →
  6. US
    Drugs & medicalClass II

    Beaver Visitec International, Inc. recalls Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807

    One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.

    FDA · DeviceBeaver Visitec International, Inc.International distribution to the countries of Belgium, China, France,…Official notice →
  7. US
    Drugs & medicalClass II

    Covidien recalls Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD

    Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable

    FDA · DeviceCovidienWorldwide distribution - US: Nationwide and surrounding territories.Official notice →
See all drugs & medical recalls →