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) -…
Read the official notice →- Date
- 2022-06-29
- Country
- United States
- Brand
- Smiths Medical ASD
- Product
- 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,…
- Classification
- Class I
- Units
- Worldwide distribution. US nationwide including US Virgin Islands, Countries…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-05-24
USSmiths 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 → - 2022-11-30
- 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 → - 2022-02-23
- 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 → - US
Smiths Medical ASD Inc. recalls Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Two devices were labeled with the same serial number
Other drugs & medical recalls in the United States
- 2022-06-29
- US
Olympus Corporation of the Americas recalls EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus,…
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190…
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the states of AL, FL, NC, NY.Official notice → - US
Olympus Corporation of the Americas recalls Colonovideoscope Model CF-H180AL
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out…
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution in the state of KY.Official notice → - US
Bard Peripheral Vascular Inc recalls REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag,…
FDA · DeviceBard Peripheral Vascular IncWorldwide distribution - US Nationwide distribution in the states of MS, NC,…Official notice → - US
Alcon Laboratories Ireland, Ltd recalls Alcon Clareon IOL with AutonoMe Delivery System
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
FDA · DeviceAlcon Laboratories Ireland, LtdU.S.: AL, CA, FL, GA, IA, IL, KY, LA, MI, MO, NY, OH,OK, TX, VA, and WI…Official notice → - US
Medtronic Inc recalls HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete…
FDA · DeviceMedtronic IncWorldwide Distribution. US nationwide, Austria, Belgium, Finland, France,…Official notice → - US
Teva Pharmaceuticals USA Inc recalls Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.