FDA-Device2017-11-15Class II
Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50
Bioseal Corporation
Hazard
Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.
Sold states
CA, IL, NC, VT
Affected count
51635 units
Manufactured in
167 W Orangethorpe Ave, N/A, Placentia, CA, United States
Products
Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0085-2018Don't want to check this manually?
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