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…
Read the official notice →- Date
- 2023-04-05
- Country
- United States
- Brand
- Atrium Medical
- Product
- Express Mini 500 Dry Seal Chest Drain, Part Number 16400
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of United Arab…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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USAtrium Medical Corporation recalls Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
FDA · DeviceAtrium Medical CorporationUS: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TXOfficial notice →- 2023-11-22
- US
Atrium Medical Corporation recalls Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection…
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
Atrium 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.
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- 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 → - 2022-07-06
- US
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…
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- 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…
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Other drugs & medical recalls in the United States
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Quidel Corporation recalls MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037,…
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Instrumentation Laboratory recalls ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or…
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Presence of misleading label statements on the product label.
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