FDA DeviceClass IINotable
FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK
Description
Unapproved design changes to the products outside of the 510(k) clearance.
Hazard
Unapproved design changes to the products outside of the 510(k) clearance.
Remedy
270,311 total
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