FDA DeviceClass IINotable
FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK D
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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