Recall Z-0085-2018 ยท KDD Kit, Surgical Instrument, Disposable
Bioseal Corporation
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
| Date | Oct 18, 2017 |
| Status | Completed |
| Reason | Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated the recall by letter on 10/18/2017. The letter requested the consignee discontinue use of the product and notify the recalling firm with the quantities on hand for return. Those consignee who further distributed the product were directed to notify their customers and have the affected products returned to them for return to Bioseal. |
| Quantity | 51635 units |
| Distribution | CA, IL, NC, VT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.