Convenience Kits Recalled Because They Include High-Risk Monoject Syringes From Cardinal Health
More than 9,000 of the kits made by Aligned Medical Solutions have been recalled because they include a prefilled saline syringe that was the subject of a high-risk class I recall.
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Q3 Recalls Snapshot: Cardinal Health’s Recall Of 267 Million Syringes Causes Recalled Units To Swell
The number of recalled device units ballooned to a whopping 372,215,986 in the third quarter of 2021, mostly driven by an August recall of Monoject Flush Prefilled Saline Syringes by Cardinal Health. Check out our Q3 recalls infographic.
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.
In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down.