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Products contain undeclared wheat.
CGMP Deviations
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards.
The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards. Cronobacter spp. detected by FDA sampling.
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
Due to Salmonella in Cucumbers
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Lack of Assurance of Sterility: Leaking vials
High coliform and generic E. coli count
Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.