Recall Z-0085-2018— Bioseal Corporation
Class II · Completed
Class II FDA medical device recall by Bioseal Corporation, initiated 2017-10-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date..
- Recalling firm
- Bioseal Corporation
- Classification
- Class II
- Status
- Completed
- Initiated
- 2017-10-18
- Firm location
- Placentia, CA, United States
Product description
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
Reason for recall
Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.
Data sourced from openFDA. This site is unofficial and independent of the FDA.