Recall Z-2583-2021 ยท ITX Transducer, Ultrasonic, Diagnostic
North Coast Medical Inc
EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
| Date | Aug 27, 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 08/17/2021, an online posting went live informing customers to discontinue use of affected products. On 08/27/21, recall notices were mailed to customers. Customers were asked to do the following: 1) Immediately examine your inventory and discontinue use, quarantine, and stop distribution of all affected gels and lotions manufactured by Eco-Med Pharmaceutical. 2) If affected product has been further distributed, notify customers, and forward the recall notification down to the user level. If you have any questions concerning this communication, please don t hesitate to contact NCMRecall@n |
| Quantity | 53 |
| Distribution | Worldwide distribution. US nationwide, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, Grand Cayman, and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962840 | ECOLOTION TRANSMISSION AND MASSAGE LOTION Eco-Med Pharmaceuticals, Inc., Dec 23, 1996 |