Supply Chain

Managing supplies is a crucial part of moving medical products from the manufacturer to patient’s bedside. Efficient supply chains can reduce healthcare costs and make medical devices more affordable for patients and health systems. This news page includes content on supply shortages, inventory management, and procurement practices.

FDA designates recall of Hamilton breathing circuits a Class I
Two lots of breathing circuits manufactured by Hamilton Medical have a defect that could cause the tubing to splinter. The affected devices must be quarantined, as they cannot be safely used on patients.
FDA announces recall of Integra applicators due to sanitation risk
Multiple lots of extended tip applicators from Integra LifeSciences could put patients at risk of serious infection, prompting the FDA to designate the recall as Class I.
B. Braun recalls IV solutions over serious patient safety risks
Two lots of IV solution bags from the company were found to contain particulate matter that could cause blockages in blood vessels, killing a patient. To date, no serious adverse events have been reported.
Error with Tandem insulin pumps causes 700 adverse events, 59 injuries
A malfunctioning speaker is being blamed for the error code, which effectively pauses infusions on t:slim X2 insulin pumps. Tandem Diabetes Care has promised to release a software patch to improve the safety of the devices.
FDA issues early alert on Baxter infusion pumps after 3 serious injuries
Some Baxter Novum IQ pumps have a software issue that can cause the “run” screen to go blank or trigger another system error, potentially resulting in inadequate infusion. The company has issued updated use instructions to ensure safe operation.

FDA designates recall of Hamilton breathing circuits a Class I

Two lots of breathing circuits manufactured by Hamilton Medical have a defect that could cause the tubing to splinter. The affected devices must be quarantined, as they cannot be safely used on patients.

FDA announces recall of Integra applicators due to sanitation risk

Multiple lots of extended tip applicators from Integra LifeSciences could put patients at risk of serious infection, prompting the FDA to designate the recall as Class I.

B. Braun recalls IV solutions over serious patient safety risks

Two lots of IV solution bags from the company were found to contain particulate matter that could cause blockages in blood vessels, killing a patient. To date, no serious adverse events have been reported.

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Error with Tandem insulin pumps causes 700 adverse events, 59 injuries

A malfunctioning speaker is being blamed for the error code, which effectively pauses infusions on t:slim X2 insulin pumps. Tandem Diabetes Care has promised to release a software patch to improve the safety of the devices.

FDA issues early alert on Baxter infusion pumps after 3 serious injuries

Some Baxter Novum IQ pumps have a software issue that can cause the “run” screen to go blank or trigger another system error, potentially resulting in inadequate infusion. The company has issued updated use instructions to ensure safe operation.

warning safety alert recall healthcare issue

FDA recalls breathing system filters after multiple injuries

Multiple lots of Draeger SafeStar and TwinStar filters—which are typically used during mechanical ventilation—are being removed from where they’re used and sold due to erroneous carbon dioxide readings.

Helene damage to bridge Baxter North Cove facility in North Carolina.

FDA confirms end to IV saline shortage caused by Hurricane Helene

Nearly 11 months after the hurricane flooded a Baxter manufacturing facility near Asheville, North Carolina, the resulting nationwide shortage of saline solution bags is officially over.

Assembly issue spurs FDA recall on manual resuscitators

A problem with the B/V filters on SunMed adult resuscitators can cause the devices to malfunction. Due to the high safety risk this poses to patients, the FDA has assigned this recall its most serious designation.