FDA Recall
Open, Classified
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Recall: Z-0224-2022
·
Initiated August 18, 2021
Recall
- Recall Number
- Z-0224-2022
- Event Number
- 88751
- Firm
- Scrip Inc
- FEI Number
- 1457081
- Product Code
- ITX
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- August 18, 2021
- Address
- 9005 N Industrial Rd, Peoria, IL, 61615-1511
Description
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Reason
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Action
The recalling firm, allegromedical, issued "URGENT Action Required" correspondence on or around 10/12/2021 informing customers of the recall and to stop use of the product. If product was further distributed, customers are asked to notify additional recipients of the product recall. If you have any questions, contact VP of Operation at 630-771-7410 or email: [email protected].
Distribution
US Nationwide Distribution to all 50 states.
Quantity
1001 gallons