Recall Z-0224-2022 ยท ITX Transducer, Ultrasonic, Diagnostic
Scrip Inc
Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
| Date | Aug 18, 2021 |
| Status | Open, Classified |
| Reason | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. |
| Root cause | Process control |
| 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: lpantera@scripco.com. |
| Quantity | 1001 gallons |
| Distribution | US Nationwide Distribution to all 50 states. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955246 | ECOGEL 200 ULTRASOUND GEL Eco-Med Pharmaceuticals, Inc., Feb 21, 1996 |