Medline Industries, LP: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PACK DYNJ51124B LIPO SUPPLEMENT PACK-LF DYNJ0341174D PLASTIC PACK DYNJ66746 DYNJ85

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: DYNJ51124B UDI-DI 10193489579291 Lot 24ABS353 DYNJ0341174D UDI-DI 10195327437749 Lot 24BBB383 DYNJ66746 UDI-DI 10193489375527 Lot 24BBD114 DYNJ85702 UDI-DI 10195327536213 Lot 24ABP053

UPC codes

10193489579291, 10195327437749, 10193489375527, 10195327536213

Source

Official record: FDA (Device enforcement) ↗

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