The new letter by FDA aimed to expand the recall notice to PCA pumps, which the original recall did not mention. It’s that gap in information that concerned FDA.

Only days after MD+DI reported Cardinal Health was embroiled in a Class I recall of its Cardinal branded Monoject syringes, FDA has moved to clarify its advice for clinicians specific to the recall.

The Monoject syringes are part of Covidien’s portfolio that Cardinal brought from Medtronic for $6.1 billion in 2017. In June of this year, they changed the text on the syringes, branding it under Cardinal, which changed the dosing dimensions.

It was the difference of dimensions that initially sparked the recall after it was reported to affect use with syringe pumps, potentially resulting in pump performance issues like overdose, underdose, delay in therapy, and delay in occlusion alarms.

The new notice published by FDA, titled “Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps” aimed to expand the notice to PCA pumps, which the original recall did not mention. FDA said that it’s that gap in information which concerned them. “The FDA has concerns that the information provided by Cardinal Health has not sufficiently mitigated the risk of incompatibility when Cardinal Health Monoject syringes are used with other pumps, specifically PCA pumps,” the agency wrote.

Along with the agency’s advice not to use the recalled syringes with PCA pumps, it also updated its recommendations regarding the use of older Coviden Monoject syringes.

“Do not use Cardinal Health Monoject syringes with syringe pumps or PCA pumps,” FDA wrote. “You may continue to use Covidien Monoject syringes with syringe pumps or PCA pumps. Be aware that both brands of syringes state only ‘monoject’ on the syringe itself and do not include the company name. Keep the outer packaging with the Covidien Monoject syringe prior to using it with a syringe pump or PCA pump in order for end-users to verify that the syringe can be used.”

FDA noted it also had concerns that the incompatibility of the syringes could apply to additional sizes not listed in the recall and said officials are working with the manufacturer to address these questions.

Article Source：MDDI