FDA DeviceClass IINotable
FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BOD
Description
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Hazard
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Remedy
113,843 kits
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