Medtronic Perfusion Systems recalls Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF…
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or…
Read the official notice →- Date
- 2023-02-08
- Country
- United States
- Brand
- Medtronic Perfusion Systems
- Product
- Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF…
- Classification
- Class II
- Units
- Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Medtronic Perfusion Systems recalls
- 2024-07-31
USMedtronic Perfusion Systems recalls TourniKwik Tourniquet Set (CFN 79012)
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
FDA · DeviceMedtronic Perfusion SystemsWorldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and…Official notice →- 2024-05-22
- US
- 2024-03-27
- US
Medtronic Perfusion Systems recalls Medtronic DLP Vessel Cannula, Model Number REF 30000
Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
FDA · DeviceMedtronic Perfusion SystemsUS and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy,…Official notice → - 2022-06-01
- US
Medtronic Perfusion Systems recalls Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the…
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide distribution in the states of CA, ND,…Official notice → - 2022-01-19
- US
Medtronic Perfusion Systems recalls Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R…
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice → - 2021-12-01
- US
Medtronic Perfusion Systems recalls Cardioblate CryoFlex Surgical Ablation Console
There is potential for intermittent electrical connectivity between the console and probe.
FDA · DeviceMedtronic Perfusion SystemsDistribution in US - IL, KS, and UT Distribution outside of US to Australia…Official notice →
Other drugs & medical recalls in the United States
- 2023-02-08
- US
Turbett Surgical, Inc. recalls Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
FDA · DeviceTurbett Surgical, Inc.US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA,…Official notice → - US
Biomet, Inc. recalls OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone,…
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of AR, MD, WA, WI.Official notice → - US
SynCardia Systems LLC recalls SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Due to tears reported tears in the cannula due to wear and tear stress.
FDA · DeviceSynCardia Systems LLCWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice → - US
Smiths Medical ASD Inc. recalls CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6)…
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
FDA · DeviceSmiths Medical ASD Inc.Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR,…Official notice → - US
Universal Meditech Inc. recalls Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under…
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
FDA · DeviceUniversal Meditech Inc.U.S. Nationwide distribution in the states of CA, and TX.Official notice →