Class I - Dangerous
Devices were delivered without the required dry ice.
💧
Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.
Abbott Ireland Diagnostics Division
Class I - Dangerous
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
Class I - Dangerous
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
Class I - Dangerous
Devices were delivered without the required dry ice.
Class I - Dangerous
Devices were delivered without the required dry ice.
Class I - Dangerous
Devices were delivered without the required dry ice.
Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.
Abbott Ireland Diagnostics Division
Class I - Dangerous
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Cardinal Health 200
Class I - Dangerous
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Carolina Liquid Chemistries
Class I - Dangerous
CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Carolina Liquid Chemistries
Class I - Dangerous
Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life.
Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which may result in the centrifuge tubing line making contact with the washing chamber. The contact may result in excessive wear of the centrifuge tubing or in extreme cases a puncture of the tubing.
Class I - Dangerous
In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
Class I - Dangerous
The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.
Class I - Dangerous
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Class I - Dangerous
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Class I - Dangerous
New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
Becton Dickinson & Company
Class I - Dangerous
The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.
Johnson & Johnson Vision Care
Class I - Dangerous
One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.