Cardinal Health: Recall Of 267 Million Monoject Syringes May ‘Contribute To Market Disruption’

The recall of such a massive number of syringes could cause supply problems

The prefilled saline syringes were recalled because they could “reintroduce air into the syringe after the air has been expelled,” the manufacturer explains. The US FDA on 23 August affixed its highest risk classification, class I, to the recall. 

A logo sign outside of the headquarters of Cardinal Health, Inc., in Dublin, Ohio
(Alamy Stock Photo)

A recall by Cardinal Health Inc. of a massive number of prefilled saline syringes could make it difficult for health care providers to find equivalent products.

Roughly 267 million of the company’s Monoject Flush Prefilled Saline Syringes (0.9% Sodium Chloride) were recalled on 4 August because...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Recalls

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By 

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

Serious Injuries Tied To Medtronic Bravo GERD Diagnosing System

 

The US FDA has issued an early alert to notify consumers about serious risks associated with a recall from Medtronic and its subsidiary Given Imaging. The alert concerns delivery capsules for diagnosing GERD.

More from Policy & Regulation

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 

A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.

With CMS Coverage Established, Medtronic Looks To Next Steps For Renal Denervation

 
• By 

US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the

House Bill Calls For ‘Non-Flushable’ Label On Personal Wipes

 

The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.