Medical Device Recalls: Recent Updates | Becker’s Hospital Review
- The Food adn Drug Administration (FDA) has announced several medical device recalls this June, citing potential risks to patient safety.
- Q’Apel Medical initiated a medical device recall of its hippo 072 aspiration system, which includes the Cheetah delivery tool and aspiration tubing.This action followed an FDA warning letter.
- Another important medical device recall involves Medline Industries' neonatal and pediatric convenience kits.
The FDA has announced critical medical device recalls this June, affecting the safety of patients. These recalls involve the Hippo 072 aspiration system,used in stroke treatment,neonatal and pediatric intubation kits,and blood management sets. Q’Apel Medical recalled its aspiration system due to potential blood vessel damage, while Medline Industries recalled intubation kits that could lead to under-ventilation issues. Further, fresenius Kabi issued a recall for blood administration sets with misassembly concerns. stay informed with News Directory 3 for the latest updates in the medical field. Healthcare providers and individuals should take immediate action by checking inventory and following manufacturer instructions for returning or replacing faulty devices. Discover what’s next in medical safety protocols.
FDA Announces Medical Device Recalls: aspiration System, intubation Kits
The Food adn Drug Administration (FDA) has announced several medical device recalls this June, citing potential risks to patient safety. These recalls include an aspiration system used in stroke treatment, neonatal and pediatric intubation kits, and blood administration sets.
Q’Apel Medical initiated a medical device recall of its hippo 072 aspiration system, which includes the Cheetah delivery tool and aspiration tubing.This action followed an FDA warning letter. The devices, designed to remove blood clots in stroke patients, may have design flaws at the distal tip. these flaws could lead to serious complications, including blood vessel tears, vasospasm, or even death. To date, two injuries have been reported in connection with this issue, but no deaths.
Another important medical device recall involves Medline Industries’ neonatal and pediatric convenience kits. These kits contain Smiths Medical endotracheal tubes that may have a smaller-than-expected diameter. This discrepancy could result in underventilation, hypoxia, or cardiopulmonary arrest in vulnerable patients. Eight injuries have been reported in connection with these faulty intubation kits; no deaths have occurred.
Fresenius Kabi also issued a medical device recall for a specific lot of its LVP blood administration sets. The recall was prompted by the finding of incorrect assembly: the primary and secondary inlet lines were reversed. This misassembly could lead to the infusion of unfiltered blood, possibly causing embolism, sepsis, or delays in necessary therapy. As of now, no injuries or deaths have been reported related to this issue.
What’s next
The FDA continues to monitor these situations and work with the respective companies to ensure that affected devices are removed from circulation and that healthcare providers are aware of the potential risks. Patients and healthcare professionals are advised to check their inventory and follow the instructions provided by the manufacturers for returning or replacing the recalled devices.