Bioseal Corporation

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1623-2021Class IIBioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EMarch 23, 2021
Z-1622-2021Class IIBioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EMarch 23, 2021
Z-1624-2021Class IIBioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EMarch 23, 2021
Z-2795-2020Class IIBioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date ofAugust 15, 2019
Z-0085-2018Class IICustom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INSTOctober 18, 2017