Class I Recall Issued for Cancer Drug Administration Product

The FDA recently issued a recall notice for all Source Administration Sets used with the Medrad Intego PET Infusion System, which is manufactured by Bayer.

The sets are currently being recalled over reports of particulate matter in medicine vials, which are likely created when the tip of the needle pierces the rubber top of the vial containing drugs, the FDA reported in a safety alert.

If a patient receives an injection that contains particulate matter, serious adverse events, including infection, tissue damage, and death, may occur. Due to the serious nature of adverse events, the FDA issued a Class I recall, which is the most serious recall level.

The Medrad Intego PET Infusion System delivers medications by inserting the needle into a vein during nuclear medicine procedures that can diagnose and treat diseases such as cancer, thyroid conditions, and heart disease, according to the FDA.

These patients may be especially vulnerable to adverse effects from particulate matter in the vials due to compromised immune systems that are commonly experienced during treatment for certain diseases, such as cancer.

The affected product was sold between October 9, 2008 and October 11, 2016, but the recall was only recently issued, according to the press release. Patients who have been treated with the effected products during this 8-year period may have been exposed to potentially harmful particulate matter.

The FDA now recommends the discontinuation of any affected Source Administration Sets, and unused products should be quarantined. Bayer is requesting that healthcare professionals only use the Source Administration Sets when a new qualified in-line filter is received, or to contact their customer service department to arrange a return.

Any adverse events should be reported by healthcare professionals and patients to the MedWatch Safety Information and Adverse Event Reporting Program, the FDA concluded.