Recalls / —
—#180212
Product
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.
- FDA product code
- OEQ — Angiography/Angioplasty Kit
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- Merit lot number J559821
Why it was recalled
A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
The firm immediately notified the customer on 7/9/2018 to determine if the product had been used.
Recalling firm
- Firm
- Merit Medical Systems, Inc.
- Address
- 1600 W Merit Pkwy South, Jordan, Utah 84095-2416
Distribution
- Distribution pattern
- US Nationwide distribution in the state of IL. There was no other distribution.
Timeline
- Recall initiated
- 2018-07-09
- Terminated
- 2020-04-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #180212. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.