Z-0194-2022 Class I Terminated
FDA device recall Z-0194-2022 was initiated by Lumenis, Inc. on October 14, 2021 and is designated Class I. 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 thi… The recall status is terminated (terminated August 12, 2024). Affected quantity: 11,064.
Recall Details
- Product Type
- Devices
- Report Date
- November 10, 2021
- Initiation Date
- October 14, 2021
- Termination Date
- August 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,064
Product Description
Reason for Recall
Distribution Pattern
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, VA, IL, MI, NE, WY, ME, WI, OK, MS, SD, NV, AL, DC, OR, VT, ND, DE, HI and the countries of AT, AU, DE, GB, HK, IT, KR, CN, FR, IE, IN, LK, JP, MO, NZ, PR, TT, TW, MN, TH, CH.