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The field action FMI 32067/ and customer communication, plus enhanced panel design were launched in March 2019 and July 2020, respectively. However, GE Healthcare recently received one complaint of a patient fall related to the bedside panels not being…

Some cartons of the lot of Vitek 2 Ast cards have been identified as impacted by a card and/or card label mix issue during production at the manufacturing site.  The card and label of the card are incorrect and are from another Vitek 2 ID or AST…

Maquet Cardiopulmonary Gmbh (MCP) has received customer complaints of damage to the primary packaging of the Hls Set Advanced. In all it was reported that the Tyvek cover was damaged. Investigation suggest that the Tyvek damage only occurs if the set…

This recall addresses an incorrect needle size concern in the kits. Some of the needles for product code 80-8139 and lot 163309 contained shorter sized needles instead of the labelled larger size (3.5 inch). Recall start date: July 14, 2022

The former packaging design of HLS set contains accessories packed in medical paper as opposed to the new introduced packaging design in Tyvek. Based on design verification tests it showed that medical paper is a weaker technical solution than Tyvek,…

Zimmer GmbH is conducting a medical device field safety corrective action (removal) for one lot of the NCB femoral screws. The product in scope is part of a mix-up with a NCB humeral screw that differs in dimensions and therefore it has been decided to…

During an internal review, it was determined that the Cathcart head includes a +5mm offset, which was not specified in previous versions of the self-centering bipolar and Modular Cathcart unipolar endo heads surgical technique…

Hillrom received reports of mislabeled fiberoptic Mac #1 laryngoscope blades (p/n 69061 lot 21-056). The outer box label stated Mac #1 laryngoscope blades (p/n 69061), but actually contained Mac #2 laryngoscope blades (p/n…

Alere San Diego has identified that bilirubin interference level listed in the package insert is incorrect. Concentrations less than 5.0 mg/dl can impact the accuracy of triglyceride (TRG) and High-density lipoproteins (HDL). Bilirubin levels of 2.0 mg/…

Olympus has received a limited number of complaints that the laser fiber size on the label did not match the product's size. These complaints were identified by users during preparation for use. Olympus investigations confirmed…

Stryker has identified a nonconformance (via product complaint june 2021) relating to the infinity™ resection guide. specifically, the products were incorrectly color-coded with yellow ink instead of blue ink. The device is…

An increase in complaints related to incomplete seals or the dressing been trapped in packaging was observed. As a potential hazard associated with these complaints involve the dressing being open or the product being sealed within the same primary…

Avanos medical is conducting a voluntary field correction for the Cortrak* 2 Enteral Access System (Eas) because modifications to the labeling of the device have been initiated. Reports of injuries and patient deaths related to misplacement of…

This recall notice describes a labelling update to correct the instructions for use for the flexible endoscopes identified to advise that high-level disinfection and, for specific models, liquid chemical sterilization, should not be used as methods of…

Baxter Corporation has received one complaint of a customer getting self-righting luer lock tip caps, yellow (product code h938690025) mislabeled as self-righting luer slip tip caps, yellow (product code h93866100). Recall start date: Feb 28, 2022