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Showing 3541–3560 of 8389 results

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Mojo Non Vented Full Face Mask (SleepNet) – Magnet Warning Update (2024)

Update to contraindications and warning language due to CPAP masks containing magnets.

FDAMar 1, 2024Nationwide• SleepNet Corporation

Centurion OB Instrument Tray (Medline) – Needle Guide Ring Detachment (2024)

Trumpet Needle Guide ring can detach when excessive pressure is applied.

FDAMar 1, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Medline Medical Procedure Kits (Medline) – Needle Guide Ring Detachment (2024)

Trumpet Needle Guide ring can detach when excessive pressure is applied.

Moderate

FDAMar 1, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Mojo 2 Full Face Non Vented Mask (SleepNet) – Magnet Warning Update (2024)

Update to contraindications and warning language due to CPAP masks containing magnets.

FDAMar 1, 2024Nationwide• SleepNet Corporation

Mojo 2 Full Face Vented Mask (SleepNet) – Magnet Warning Update (2024)

Update to contraindications and warning language due to CPAP masks containing magnets.

FDAMar 1, 2024Nationwide• SleepNet Corporation

Dilator With AQ Hydrophilic Coating (Cook) – Packaging Seal Strength Issue (2024)

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

FDAMar 1, 2024Nationwide• Cook Incorporated

Cholestech LDX Battery Kit (Alere) – Battery Pack Issue (2024)

There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.

FDAMar 1, 2024Nationwide• Alere San Diego, Inc.

DxI 9000 Access Immunoassay Analyzer (Beckman Coulter) – Pneumatic Tubing Disconnect (2024)

Laceration Risk

The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an artificially higher signal (RLU). The analyzer may not detect this splashing and continue with normal operation, which can cause false low or high erroneous results. Consequently, the analyzer may cancel in-progress tests. These errors could potentially cause delay reporting patient test results and patient treatments. The degree of the potential health hazard is dependent on the analytes that are potentially delayed, especially those analytes that would be used in the acute setting when treatment decisions are immediate. In this particular recall the highest risk analyte is troponin. Health consequences could include permanent impairment or possibly death if medical treatment decisions are delayed due to a delay in obtaining patient results. The issue was identified by Beckman Coulter Inc. manufacturing staff at their location in Brea California on February 29, 2024, during in-process acceptance inspection activities.

FDAFeb 29, 2024Nationwide• Beckman Coulter, Inc.

BD Phoenix NMIC-306 Panel (Becton Dickinson) – Drug Cross Contamination (2024)

Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results

FDAFeb 29, 2024Nationwide• Becton Dickinson & Co.

BD Phoenix Yeast ID Panel (Becton Dickinson) – Substrate Misplacement (2024)

Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abort the panel with the message Fluorescent interference has been detected. Esculin is expected to trigger this fluorescence and test cancellation.

FDAFeb 29, 2024Nationwide• Becton Dickinson & Co.

Supple Peri-Guard Repair Patch (Baxter) – Neurosurgery Contraindication (2024)

A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.

FDAFeb 28, 2024CT, IL, PA +2 more• Baxter Healthcare Corporation

Mariner RDX MIS Polyaxial Head (SeaSpine) – Screw Head Threading Risk (2024)

Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

FDAFeb 28, 2024CA, CO, FL +1 more• SEASPINE ORTHOPEDICS CORPORATION

Covidien Auto Suture Blunt Tip Trocar (Unknown) – Trocar Seal Disengagement (2024)

The potential for trocar seal disengagement when using mesh products incorrectly with the device.

FDAFeb 28, 2024Nationwide

Covidien Auto Suture Trocar (Unknown) – Trocar Seal Disengagement (2024)

The potential for trocar seal disengagement when using mesh products incorrectly with the device.

FDAFeb 28, 2024Nationwide

Peri-Guard Repair Patch (Baxter) – Neurosurgery Contraindication (2024)

A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.

FDAFeb 28, 2024CT, IL, PA +2 more• Baxter Healthcare Corporation

Patient Information Center iX (Philips) – Mobile App Ringtone Issue (2024)

It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.

FDAFeb 28, 2024Nationwide• Philips North America

CareEvent Event Management System (Philips) – Mobile App Ringtone Issue (2024)

It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.

FDAFeb 28, 2024Nationwide• Philips North America

Optical Scissor (Karl Storz) – Reprocessing Validation (2024)

Inadequate reprocessing validation evidence

FDAFeb 27, 2024Nationwide• Karl Storz Endoscopy

VITROS Performance Verifier II (Ortho-Clinical Diagnostics) – Diluent Mismatch (2024)

The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.

FDAFeb 27, 2024Nationwide• Ortho-Clinical Diagnostics

TRIDENTII PSL CLUSTER52E (Howmedica Osteonics) – Excessive Shell Deburring (2024)

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

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