LiquaSonic Ultrasound Gel 5L, Model No. 001222
FDA device recall Z-2392-2021 · posted 2021-09-09 · Terminated
Recall details
- Recalling firm
- Athena Medical Products Inc
- Reason for recall
- Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
- Action taken
- On August 20, 2021, the firm issued an Urgent Medical Device Recall letter to its only customer, who is a distributor. The letter explained the product issue and asked that the distributor identify their customers and notify them at once of the product recall. ALL lots of product should be returned or destroyed. Athena will no longer purchase or distribute products manufactured by Eco-Med. If you or your customers have any questions you can call the Recall Coordinator at 888-216-7307 or email athena8649@stericycle.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 480 cases of 4
- Distribution
- Distributed to one distributor within the US.
- Date initiated
- 2021-08-20
- Date posted
- 2021-09-09
- Date terminated
- 2023-02-02
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECOGEL 200 ULTRASOUND GEL (K955246) | Eco-Med Pharmaceuticals, Inc. | 1996-02-21 |