Ultrasonic Probe Cover Recalled Due to Lack of FDA Clearance for Body Cavity Use
Exact Medical Manufacturing is recalling 12,650 ultrasonic probe covers (Item A-AU-0980N) that were marketed for use in body cavities without FDA 510(k) clearance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a device marketed without required 510(k) pre-market clearance for use in body cavities. While no illnesses or injuries have been reported, the lack of regulatory clearance for intrusive body cavity use represents a risk-of-harm scenario meeting the rubric threshold for High severity.
Plain-English summary
Exact Medical Manufacturing is recalling approximately 12,650 ultrasonic probe covers (Item ID: A-AU-0980N) distributed to healthcare facilities in the United States.
The probe covers were marketed and distributed for use in natural or surgical body openings without obtaining the required FDA 510(k) pre-market clearance. This clearance is necessary to ensure the device is safe and effective for its intended use.
The affected product was distributed to states including Florida, Montana, New York, Ohio, and Georgia, as well as Puerto Rico. The recall applies to units with the following lot numbers: 2003E829, 2003E242, 2004E033, 2005E165, 2005E164, 2005E176, 2005E440, 2011E107, 2011E250, 2101E070, and 2012E509.
Healthcare facilities and providers should discontinue use of the recalled units immediately. Customers should contact Exact Medical Manufacturing regarding options for return or replacement of the product.
The recalled product
- Product
- Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- unapproved-use
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
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