All Recalls

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

New User Manual with additional instructions for use and a hose and mask adapter provided by the device manufacturer. This voluntary recall is intended to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device.

Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.

Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.

In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

Surgical gowns were manufactured with the wrong sleeve.

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.

The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.