Transducer Cover Lacks FDA 510(k) Clearance for Surgical Use
Exact Medical Manufacturing is recalling 500 ultrasound transducer covers lacking FDA 510(k) clearance for body cavity use. The affected lot 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 FDA Class II device lacks required 510(k) premarket clearance for use in natural or surgical body openings, representing a risk-of-harm situation where safety and effectiveness have not been FDA-validated. No reported illnesses or injuries are documented, placing it in the High category per the rubric.
Plain-English summary
Exact Medical Manufacturing, Inc. is recalling 500 units of Transducer Cover 18x147cm (Item ID: E6360) from Lot Number 2003E691. The product is intended for use as an ultrasonic transducer cover but lacks FDA 510(k) premarket clearance required for devices used in natural or surgical body openings.
The recalled product was distributed to healthcare facilities in Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
FDA 510(k) clearance is required to establish that medical devices intended for use in body cavities or surgical openings meet FDA safety and effectiveness standards. The absence of this clearance indicates the device has not undergone required FDA review for its intended use.
The recalled product
- Product
- Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360
- Manufacturer
- Exact Medical Manufacturing, Inc.
- Hazard
- regulatory-non-compliance
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: 2003E691
Distribution
Distributed in 5 states:
- FL
- GA
- MT
- NY
- OH
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