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
Read the official notice →- Date
- 2023-02-08
- Country
- United States
- Brand
- Smiths Medical ASD
- Product
- 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)…
- Classification
- Class I
- Units
- Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Smiths Medical ASD recalls
- 2023-10-18
USSmiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice →- 2023-09-06
- US
Smiths Medical ASD Inc. recalls PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
- 2023-05-24
- US
Smiths Medical ASD Inc. recalls DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with…
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide and the countries of Canada, New…Official notice → - 2022-11-30
- US
Smiths Medical ASD Inc. recalls Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming…
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
FDA · DeviceSmiths Medical ASD Inc.US distribution to states of: Indiana, Texas and VirginiaOfficial notice → - 2022-06-29
- US
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306,…
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) -…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution. US nationwide including US Virgin Islands, Countries…Official notice → - 2022-02-23
- US
Smiths Medical ASD Inc. recalls Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time…
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the…
FDA · DeviceSmiths Medical ASD Inc.Distribution US nationwide, including PR, VI, GU, and MP. There was…Official notice →
Other drugs & medical recalls in the United States
- 2023-02-08
- 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
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…
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia,…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
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 → - US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical…
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
- US