Medical device recalls, whether voluntary or mandated, are crucial for ensuring patient safety.
Here are three significant recalls reported to the FDA:
1. Fresenius Kabi USA recalls Ivenix large-volume pumps
Fresenius Kabi USA issued a recall for a subset of Ivenix large-volume pumps (LVP-0004) due to a malfunctioning pneumatic valve that may trigger a nonrecoverable pump problem alarm. The failure could interrupt critical infusions, potentially leading to an underdose or delayed therapy, which could result in permanent disability or death. Health providers are advised to remove affected units from circulation or enhance clinical monitoring if removal is not feasible. There have been no reported injuries or deaths.
2. Cardinal Health recalls Monoject U-100 insulin syringes
Cardinal Health recalled certain lots of Monoject U-100 1 mL insulin syringes with tip cap soft packs due to incompatibility with needleless connectors. Using the syringes to administer IV push insulin through these connectors may lead to incomplete medication delivery, risking hyperglycemia, diabetic ketoacidosis or death. There have been no reported injuries or deaths.
3. GE HealthCare updates use instructions for Giraffe Incubator Carestations
GE HealthCare has updated the use instructions for its Giraffe OmniBed and Incubator Carestation models due to concerns over formaldehyde exposure, according to an FDA alert applied to units received before Sept. 5, 2023. Preliminary testing showed that new units could emit higher levels of formaldehyde during the first week of use. Although the exposure decreases after a week, GE recommends that new units be run in well-ventilated areas before clinical use. There have been no reported injuries or adverse health effects.
In an email shared with Becker's, a GE HealthCare spokesperson stated, "Patient safety is our top priority. This is the same issue that was communicated by GE HealthCare and FDA in June 2023. All actions have been completed and no actions remain. We implemented steps during manufacturing to address the issue."