Unomedical A/S recalls Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with…
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
Read the official notice →- Date
- 2022-10-05
- Country
- United States
- Brand
- Unomedical A/S
- Product
- Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with…
- Classification
- Class II
- Units
- Distribution was made to California. There was no government/military…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Unomedical A/S recalls
- 2024-09-25
USUnomedical A/S recalls VariSoft Infusion Set, Single Use.
Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set".
- 2024-04-24
- US
Unomedical A/S recalls Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for…
- 2023-11-29
- US
Unomedical A/S recalls VariSoft infusion set, Model Number 1002828
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily…
Other drugs & medical recalls in the United States
- 2022-10-05
- US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwided Foreign: Afghanistan¿¿¿¿ Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿…Official notice → - US
Olympus Corporation of the Americas recalls Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device…
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
FDA · DeviceOlympus Corporation of the AmericasNationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREAOfficial notice → - US
Tandem Diabetes Care Inc recalls t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump…
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a…
FDA · DeviceTandem Diabetes Care IncUS: NC, OK, ME, NY, TX, LA, NE, FL, AZ, IL, OH, CA, AL, MI, UT, VA, MA, SC,…Official notice → - US
Mckesson Medical-Surgical Inc. Corporate Office recalls SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X…
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
FDA · DeviceMckesson Medical-Surgical Inc. Corporate OfficeUS Nationwide distribution.Official notice → - US
Micro-X Ltd. recalls MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions
FDA · DeviceMicro-X Ltd.Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include: . CUBEX MedFlex operating with Windows 7 .…
The automated dispensing cabinet software update included a .dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet system will stop functioning (Matrix drawers will stop…
FDA · DeviceCareFusion 303, Inc.U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO,…Official notice →