Recall Z-1702-2020 ยท OEQ Angiography/Angioplasty Kit
Merit Medical Systems, Inc.
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin
| Date | Jul 9, 2018 |
| Status | Terminated |
| Reason | A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer. |
| Root cause | Nonconforming Material/Component |
| Action | The firm immediately notified the customer on 7/9/2018 to determine if the product had been used. |
| Quantity | 6 units |
| Distribution | US Nationwide distribution in the state of IL. There was no other distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.