FDA Recall
Terminated
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 infection.
Recall: Z-1702-2020
·
Initiated July 9, 2018
Recall
- Recall Number
- Z-1702-2020
- Event Number
- 85171
- Firm
- Merit Medical Systems, Inc.
- FEI Number
- 1721504
- Product Code
- OEQ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 9, 2018
- Terminated
- April 14, 2020
- Address
- 1600 W Merit Pkwy South, Jordan, UT, 84095-2416
Description
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 infection.
Reason
A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
Action
The firm immediately notified the customer on 7/9/2018 to determine if the product had been used.
Distribution
US Nationwide distribution in the state of IL. There was no other distribution.
Quantity
6 units