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
Read the official notice →- Date
- 2022-11-30
- Country
- United States
- Brand
- Smiths Medical ASD
- Product
- Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP)…
- Classification
- Class II
- Units
- US distribution to states of: Indiana, Texas and Virginia
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-09-06
USSmiths 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 → - 2023-02-08
- 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 → - 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 → - 2021-11-03
- US
Smiths Medical ASD Inc. recalls Bivona Aire-Cuf Endotracheal Tube
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice →
Other drugs & medical recalls in the United States
- 2022-11-30
- US
Pajunk Medical Systems, L.P. recalls PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101,…
The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.
FDA · DevicePajunk Medical Systems, L.P.US Nationwide distribution in the states of CA, NC, TN, PA, and TX.Official notice → - US
American Contract Systems, Inc. recalls BASIN SET, MEBS42K, general surgical kit
Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
- US
Corin Ltd recalls Unity Total Knee System. Used for knee prosthesis in total knee replacement
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
FDA · DeviceCorin LtdDistribution in the US to New Jersy and Puerto Rico. International…Official notice → - US
Kamiya Biomedical Company, LLC recalls K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
FDA · DeviceKamiya Biomedical Company, LLCWorldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA,…Official notice → - US
Endo-Therapeutics, Inc. recalls eSuction Small Cavity, Model ET2005
Improper device regulatory classification
- US
Beckman Coulter, Inc. recalls MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
FDA · DeviceBeckman Coulter, Inc.Worldwide - U.S. Nationwide distribution in the states of AK, FL, IA, ID, MI…Official notice →