Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.
Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. after 6 months. The HemoCue Glucose 201 Analyzer with plasma conversion multiplies the measured whole blood glucose value by a factor of 1.11 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are for In Vitro Diag
Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile
Baxter Corporation Englewood
Class I - Dangerous
Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.
Class I - Dangerous
Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.
Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which
Class I - Dangerous
Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.
Product not approved for use in the US
Class I - Dangerous
Packaging non-conformance related to the integrity of the sterile pouch seal.
STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Advanced Sterilization Products
Class I - Dangerous
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
Class I - Dangerous
The cuff inflation line may detach from the endotracheal tube during use.
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
Siemens Healthcare Diagnostics
Class I - Dangerous
A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
Class I - Dangerous
The cuff inflation line may detach from the endotracheal tube during use.
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Unistrip Technologies
Class I - Dangerous
Failure to submit a 510(k) for device labeling changes.
Class I - Dangerous
The cuff inflation line may detach from the endotracheal tube during use.
STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Advanced Sterilization Products
Class I - Dangerous
Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.
The recalled product was distributed with an incorrect serial number printed on the device's label.
Class I - Dangerous
Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the
Class I - Dangerous
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions above V2.0.0.19 IMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist. The is