Atrium Medical Corporation recalls Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular…
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
Read the official notice →- Date
- 2021-10-06
- Country
- United States
- Brand
- Atrium Medical
- Product
- Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the state of Florida…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-04-05
USAtrium 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 → - 2022-07-06
- 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…
- 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
- US
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
- 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 → - US
Elekta, Inc. recalls MOSAIQ Oncology Information System
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
FDA · DeviceElekta, Inc.Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH,…Official notice → - US
GE Healthcare, LLC recalls AMX Navigate Mobile X-Ray System
An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
- US
ARJOHUNTLEIGH POLSKA Sp. z.o.o. recalls Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo…
The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks.
FDA · DeviceARJOHUNTLEIGH POLSKA Sp. z.o.o.US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA,…Official notice → - US
Vero Biotech, LLC recalls GENOSYL DS (Delivery System) console, for use as a vasodilator.
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
- US
Deerfield Imaging, Inc. recalls Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to…
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
FDA · DeviceDeerfield Imaging, Inc.Worldwide distribution - US Nationwide distribution FL, NH, TX, OH, CA, OR,…Official notice →