Device product
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Z-0224-2022
Product summary
- Firm
- Scrip Inc
- Event
- Event 88751
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1001 gallons
- Official record key
device-enforcement:Z-0224-2022
Official wording
Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Code information: Item Number: 663 0061, all lots bearing old style logo. Older logo states that product was manufactured by Eco-Med Pharmaceuticals in Canada.
Distribution pattern: US Nationwide Distribution to all 50 states.
Derived failure modes
-
Microbial contamination
bacterial contamination