Class I Recall For Smiths Medical’s Medfusion Syringe Pumps
The device maker recalled more than 46,000 of its Medfusion 3500 and 4000 pumps because a software error can lead to over- or under-dosing.
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For five years Owlet Baby Care Inc. has said its Smart Sock monitoring product isn’t a medical device. But the US FDA disagreed – and finally put its foot down in a warning letter that told the company to come into compliance or stop selling the sock. So Owlet decided to do both.
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 US FDA says in a report that its Inspectional Affairs Council will develop Remote Regulatory Assessment policies for all commodities the agency oversees. RRAs were launched by the FDA as a way to check on a firm’s regulatory compliance without sending an investigator on-site.