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…
Read the official notice →- Date
- 2022-05-25
- Country
- United States
- Brand
- Atrium Medical
- Product
- Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329…
- Classification
- Class I
- Units
- Foreign: Australia Austria Bahrain Belgium Bosnia-Herzegovina Brazil Bulgaria…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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…
- 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 → - US
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.
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide distribution in the state of Florida…Official notice →
Other drugs & medical recalls in the United States
- 2022-05-25
- US
Beckman Coulter Inc. recalls MicroScan WalkAway-40 plus Instrument REF B1018-283
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
FDA · DeviceBeckman Coulter Inc.Worldwide distribution - U.S. Nationwide distribution in the states of Alaska,…Official notice → - US
Boston Scientific Corporation recalls EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope…
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Getinge Usa Sales Inc recalls Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
FDA · DeviceGetinge Usa Sales IncWorldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA,…Official notice → - US
Avanos Medical, Inc. recalls Avanos Cortrak 2 Enteral Access System (EAS)
Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.
FDA · DeviceAvanos Medical, Inc.Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany,…Official notice → - US
Cardinal Health Inc. recalls Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285,…
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
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Apotex Corp. recalls Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for:…
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.