IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupli
FDA device recall Z-0194-2022 · posted 2021-11-04 · Terminated
Recall details
- Recalling firm
- Lumenis, 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 10/14/21, Recall Notification Letters and Q&A fact sheets were mailed to customers. Customers were asked to immediately stop using and discard all product subject to the recall. Customers were asked to complete and return via e-mail or fax the return response form. In addition, customers who had further distributed affected product were asked to notify their customers by sharing the recall notification letter. The following phone number was provided: 1-877-Lumenis.
- Root cause
- Process control
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 11,064
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of KS, PR, MO, MA, NJ, NH, CA, CO, GA, NC, NY, FL, AZ, ID, IN, TX, CT, WV, UT, LA, OH, KY, SC, WA, MN, AK, IA, MD, NM, TN, RI, PA, AR,
- Date initiated
- 2021-10-14
- Date posted
- 2021-11-04
- Date terminated
- 2024-08-12
- Location
- Salt Lake City, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECOGEL 200 ULTRASOUND GEL (K955246) | Eco-Med Pharmaceuticals, Inc. | 1996-02-21 |