Atrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or…
Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and…
Read the official notice →- Date
- 2022-07-06
- Country
- United States
- Brand
- Atrium Medical
- Product
- Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.…
- Classification
- Class II
- Units
- AZ IL KS LA MI NY OH OK TX VA
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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 Atrium Medical recalls
- 2023-11-22
USAtrium Medical Corporation recalls Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac…
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
FDA · DeviceAtrium Medical CorporationForeign: Australia, Belgium, Canada, France, Germany, Greece, Malta,…Official notice →- 2023-04-05
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Atrium Medical Corporation recalls Express Mini 500 Dry Seal Chest Drain, Part Number 16400
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the…
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of United Arab…Official notice → - 2022-11-23
- US
Atrium Medical Corporation recalls Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
FDA · DeviceAtrium Medical CorporationUS Nationwide distribution in the state of VA.Official notice → - 2022-05-25
- US
Atrium Medical Corporation recalls Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328…
Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible…
FDA · DeviceAtrium Medical CorporationForeign: Australia Austria Bahrain Belgium Bosnia-Herzegovina Brazil Bulgaria…Official notice → - 2021-12-01
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Atrium Medical Corporation recalls The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds…
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
FDA · DeviceAtrium Medical CorporationUS Nationwide Distribution Foreign: Bahrain Belgium Brunei Darussalam Canada…Official notice → - 2021-10-06
- US
Atrium Medical Corporation recalls Atrium Pneumostat Chest Drain Valve, Part Number 16100
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
FDA · DeviceAtrium Medical CorporationDomestic distribution nationwide. Foreign distribution worldwide.Official notice →
Other drugs & medical recalls in the United States
- 2022-07-06
- US
CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. recalls DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and…
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
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RAYSEARCH LABORATORIES AB recalls RayStation 11B
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FDA · DeviceRAYSEARCH LABORATORIES ABUS Nationwide distribution in the states of NJ and TX.Official notice → - US
Haemonetics Corporation recalls Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay -…
When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion…
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Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model #…
Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
FDA · DeviceOlympus Corporation of the AmericasNationwide distribution in the US. Foreign distribution worldwide.Official notice → - US
ROi CPS LLC recalls regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
A nonsterile component was packaged in a sterile convenience kit.
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Siemens Medical Solutions USA, Inc recalls Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
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