Atrium Medical Corporation recalls Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
Read the official notice →- Date
- 2023-12-13
- Country
- United States
- Brand
- Atrium Medical
- Product
- Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
- Classification
- Class II
- Units
- US: 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-10-16
USAtrium Medical Corporation recalls iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
FDA · DeviceAtrium Medical CorporationUS Nationwide distribution in the states of FL, MA, MI, OH, WA.Official notice →- 2024-06-12
- US
Atrium Medical Corporation recalls ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
FDA · DeviceAtrium Medical CorporationWorldwide distribution - US Nationwide including Puerto Rico, and the…Official notice → - 2024-01-03
- US
Atrium Medical Corporation recalls Atrium Oasis Drain Single W / AC, Part No. 3600-100
A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers.…
FDA · DeviceAtrium Medical CorporationDomestic distribution nationwide. No foreign distribution.Official notice → - 2023-12-13
- US
Atrium 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.
FDA · DeviceAtrium Medical CorporationForeign: Australia, Belgium, Canada, France, Germany, Greece, Malta,…Official notice →
Other drugs & medical recalls in the United States
- 2023-12-13
- US
Stanbio Laboratory, LP recalls STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified…
FDA · DeviceStanbio Laboratory, LPWorldwide - US Nationwide distribution including in the states of AZ, RI, MO,…Official notice → - US
Vyaire Medical recalls vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.
- US
Remington Medical, Inc. recalls Remington MEDICAL Drainage Bag, REF 600-D;
There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
- US
Atrium 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 → - US
Heartware, Inc. recalls PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended…
- US
Staar Surgical Company recalls EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
FDA · DeviceStaar Surgical CompanyUS: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV…Official notice →