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All product recalls affecting New Mexico.
Includes nationwide recalls (tagged “Nationwide”) and recalls with New Mexico in the distribution area.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.
Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
New Flyer of America, Inc. (New Flyer) is recalling certain 2023-2024 XDE60, 2024 XD35, XD40, and XD60 transit buses equipped with Cummins L9 diesel engines. The remote fuel filter hoses may separate from the fitting, causing a fuel leak and an engine stall.
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
Temsa is recalling certain 2024 TS35 vehicles equipped with Cummins L9 diesel engines. The remote fuel filter hoses may separate from the fitting, causing a fuel leak and an engine stall.
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. During a delivery accuracy dry run testing of the 780G NGP infusion pump under dynamic pressure conditions, the firm observed that when air pressure decreased during take-off simulation, on average 0.569U more insulin was delivered in 15 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate; when air pressure increased during landing simulation, on average 0.537 U less insulin was delivered in 25 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate. The firm also observed that the mechanisms causing the variations in delivery volumes are independent of the delivery rate.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.