Medline Industries, LP: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM SAMP0551

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.

Details from the source

Reason for recall: Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados. Quantity: 113,843 kits Lot/code info: SAMP0551 UDI-DI 10195327268503 Lots 22JBG593 22JBJ361

UPC codes

10195327268503

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.