Recall Z-0009-2022 ยท ITX Transducer, Ultrasonic, Diagnostic
DJO, LLC
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/
| Date | Sep 7, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On 09/03/21, recall notices were mailed and emailed to customers. Customers were asked to take the following action: a) Immediately remove and destroy the gel products located in the DJO, LLC / DJO FRANCE kits that contain the affected product. Follow all local/state or country regulations for disposal b) Immediately stop use of ALL ultrasound gels and lotions labeled manufactured by Eco-Med Pharmaceutical (regardless of lot). c) In addition, if you have further distributed this product, please identify your customers, and notify them at once of this product recall by sharing this recall noti |
| Quantity | 67,485 |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of ND, NJ, CO, HI, CA, MA, FL, GA, IN, WA, NY, TX, IA, TN, NV, LA, CT, VA, NC, WI, MS, OR, MI, AL, MN, VT, IL, OH, AR, NM, DE, PA, SC, AZ, MD, RI, KY, UT, MO, OK, MT, ID, NE, WY, ME, WV, SD, KS, PR, NH, DC, AK, VI and the |
| 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 |