First Source, LLC

FDA Regulatory Profile

Summary

Total Recalls
28 (12 Class I)
510(k) Clearances
3
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2247-2024Class IIFirst Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computerMay 9, 2024
Z-2246-2024Class IIFirst Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.May 9, 2024
F-0691-2019Class IIChocolate and Nut Tray. The product comes in a four-quadrant plastic tray, NET WT 37 OZ (2 LBS 5 OZ)November 20, 2018
F-1004-2018Class IWegmans Yogurt Raisins, 9 OZ (255g), in a plastic tub, UPC: 0 77890 31832 4,March 27, 2018
F-0405-2018Class IIOrganic Dark Chocolate (Covered) Raisins; Wegmans organic Dark Chocolate Covered Raisins NET WT 14 ONovember 9, 2017
F-0407-2018Class IIWegmans Organic Dark Chocolate Covered Cranberries NET WT 14 OZ (396g) UPC: 0 77890 37786 4, ProductNovember 9, 2017
F-0406-2018Class IIOrganic Dark Chocolate (Covered) Cherries: Wegmans Organic Dark Chocolate Cherries NET WT 14 OZ (396November 9, 2017
F-0481-2018Class IIWegmans Dark Chocolate Cherry Infused Cranberries 12 OZ (340g) tub UPC: 0 77890 33741 7October 30, 2017
F-0483-2018Class IITops Dark Chocolate Coffee Beans Net Wt 12 OZ (340g) UPC: 0 70784 51027 9October 30, 2017
F-0484-2018Class II(Canada) - Favourites Dark Chocolate Covered Almonds 113 grams UPC: 0 23637 42849 8 & 92grams UPC: 0October 30, 2017
F-0480-2018Class II(1)Wegmans Dark Chocolate Almonds with Sea Salt and Turbinado Sugar 12oz. tub (340g) UPC: 0 77890 3October 30, 2017
F-0485-2018Class II(Canada) Circle K Favourites Dark Chocolate Covered Almonds 113grams UPC: 0 2367 42849October 30, 2017
F-0479-2018Class IIDark Chocolate Almonds packaged under the brand names: (1)Wegmans, 23 OZ (1 LB 7 OZ) 652g tub UPC:October 30, 2017
F-0482-2018Class IIWegmans Dark Chocolate Strawberries 13.5oz (383g) tub, UPC: 0 77890 38187 8October 30, 2017
F-0087-2018Class IIApple Valley Honey Roasted Crunch, 15 lb. poly bag lined brown cardboard cases for bulk Item numberOctober 19, 2017
F-0016-2018Class IBristol Farms Tasty Treats -Nonpareils Milk Chocolate; 5 oz. plastic pouch; UPC 7 97299 00476 4 September 20, 2017
F-0722-2017Class IIIWegmans Milk Chocolate Covered Pretzels, NET WT 9.5 OZ (269g)November 11, 2016
F-0697-2017Class IROASTED & UNSALTED SUNFLOWER KERNELS sold under the following labels: 1) ROASTED & UNSALTED SUNFLOWEMay 23, 2016
F-0701-2017Class IFlave! SUNFLOWER SEEDS, NET WT 7.5OZ (212g), shipped 12 packs per caseMay 23, 2016
F-0698-2017Class ISUNSHINE CRANBERRY DELIGHT sold under the following labels: 1) Wegmans square tub SUNSHINE CRANBERRYMay 23, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K240009iQFlex ProJuly 3, 2024
K221081iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray SystemJune 13, 2022
K203703I-Q ViewMarch 24, 2021