FDA hands down 2 more Class I labels to drug delivery device recalls, now from Baxter, Fresenius

In its second and third such notices this week, the FDA doled out its most serious label to a pair of recalls of devices used in medication delivery.

The first and larger of the two recalls came from Fresenius Medical Care, which in early August issued a warning for potential issues with syringes that had been distributed between the end of April 2021 and Aug. 7 of this year, including more than 12.4 million sold in the U.S.

The recall concerns certain versions of Fresenius’ Sanxin single-use sterile syringes, which connect to mechanical syringe pumps to mix blood-thinning medicine heparin into the blood in hemodialysis machines. Each syringe is pressurized and remains connected to the machine throughout an entire hemodialysis treatment.

The affected syringes carried a risk of leaking, with either heparin or blood flowing “back or from the syringe,” according to the FDA’s Class I notice on Wednesday. If blood leaks from the syringe, it could lead to blood loss or a bloodstream infection, while a heparin leakage could result in an incorrect dosage of the medication, which can in turn lead to the development of blood clots or embolisms, or even death.

So far, Fresenius has received 37 complaints about the possibly faulty syringes, with no reports of injuries or death.

The company asked customers to identify and separate out any of the affected syringes from their storerooms and contact Fresenius’ renal therapies division for further instructions about returning the recalled products in exchange for credits.

The second of the FDA’s Wednesday Class I notices went to Baxter and described a correction to one of its drug delivery devices, rather than a full-on product removal like Fresenius’.

Baxter’s recall began in September, after finding that its Novum IQ syringe infusion pumps contained a software error that could cause the pumps to inaccurately indicate that an infusion has finished. Specifically, the error may cause the pumps’ software to miscalculate the remaining volume of a medication, blood or other fluid after it has detected a blockage, therefore determining an infusion to be complete before it actually is.

The resulting underdosing and delays in needed treatments could result in serious health effects or even death, especially among patients who are receiving life-sustaining medications and fluids through the infusion pumps, per the FDA. To date, however, Baxter hasn’t received any such reports.

The recall affects just over 2,000 pumps that were distributed in the U.S. between March and August of this year.

Rather than asking healthcare providers using the pumps to stop using and return the devices, Baxter has advised them to pay close attention to whether any fluid is left in a connected syringe after a pump says the infusion is complete, especially if the pump had previously alerted users to any blockages during the infusion period. The company is also in the process of making a software update available to correct the error.

The pair of FDA notices came after the agency issued yet another Class I notice earlier this week and to another device used to deliver medications and other needed fluids. In that case—another product correction, rather than outright removal—some batches of Cardinal Health’s Monoject syringes were found to be incompatible with syringe pumps.

Meanwhile, in a trio of additions to the regulator’s recall database last week, BD earned a Class I label for its own product update, in which it warned healthcare providers against using its Alaris syringe pumps with the faulty Monoject syringes.