Device product
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Z-0225-2022
Product summary
- Firm
- Scrip Inc
- Event
- Event 88751
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1001 gallons
- Official record key
device-enforcement:Z-0225-2022
Official wording
Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Code information: Item Number: 663 0019, all lots distributed between August 2018 and August 2021
Distribution pattern: US Nationwide Distribution to all 50 states.
Derived failure modes
-
Microbial contamination
bacterial contamination