According to the FDA, Zyno Medical issued a Class I recall on several of their infusion pumps after discovery of a potentially dangerous software malfunction. The company announced the recall on September 13th, 2024, notifying all users via an Urgent Medical Device Correction letter.
The impacted infusion pumps include the Z-800, Z-800F, Z-800W, and Z800WF. The relevant Unique Device Identifiers are 00814377102006, 00814371020020, 00814371020013, and 00814371020037. These devices are designed to deliver fluids, such as nutritional supplements and blood products to patients. Zyno Medical is recalling the infusion pumps after two reported injuries. An investigation identified a software problem that could allow larger air bubbles to enter the patient’s body. Such an event could cause serious injury to the patient, up to and including vascular embolism, stroke, injury to the heart, seizure, and even death.
Zyno Medical notified customers and health care providers of the recall, advising that the recalled pumps will require software revisions before they can be used safely. All users should cease use of the impacted devices immediately and complete the Zyno Medical Z-800, Z-800F, Z-800W, and Z-800WF Infusion Pump – Air-in-Line Software Issue – Response Verification Form. This form will ask medical facilities to verify the serial numbers of the devices in their possession and to provide contact information for any devices they have distributed. Once the forms have been submitted, the company will contact the impacted facilities to arrange for a replacement.
Anyone with questions about the recall can contact their Zyno Medical Sales Representative or reach out to the company via email at feedback@intuvie.com.
Patients and health care providers can report any new adverse health events related to Zyno Medical’s Z800 Infusion devices through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an adverse health outcome caused by a Zyno Medical Z800 Infusion device, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent further injury to patients receiving infusion treatments. Our experienced attorneys at TruLaw are prepared to learn about your story and help you build a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.