Device 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.
Z-1702-2020
Product summary
- Event
- Event 85171
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1702-2020
Official wording
Reason: A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
Code information: Merit lot number J559821
Distribution pattern: US Nationwide distribution in the state of IL. There was no other distribution.
Derived failure modes
-
Unknown
A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.