Ultrasonic Probe Covers Recalled for Missing FDA Clearance
Exact Medical Manufacturing recalls 6,000 ultrasonic probe covers lacking FDA 510(k) clearance for use in body openings. The product was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
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 is a Class II medical device intended for use in natural or surgical body openings that was distributed without required FDA 510(k) pre-market clearance. No illnesses or injuries have been reported. Per the rubric, this constitutes a risk-of-harm product where injury has not yet been reported, resulting in a score of 3 (High).
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling 6,000 Probe Cover units (polyethylene with gel and elastic bands, 6"x96", Item ID 1006664). The product was distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico under lot numbers 2002E015 and 2011E316.
The recall is due to the product lacking the FDA 510(k) pre-market clearance required for use in natural or surgical body openings.
Healthcare facilities and medical professionals who have this product should discontinue use immediately. Those with questions should contact Exact Medical Manufacturing, Inc. for instructions on handling the recalled inventory.
The recalled product
- Product
- Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- Affected units
- 6,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 2002E015 2011E316
Distribution
Part of a larger recall action
This product is one of 18 recalled by Exact Medical Manufacturing, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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