Preat Astra EV-compatible 4.2mm Digital Analog Device Recalled for Rotational Defect
Preat Corp is recalling Astra EV-compatible 4.2mm Digital Analog devices due to a manufacturing error that misaligns the rotational feature by 180 degrees. Affected units were distributed nationwide to nine states.
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: Class II device with manufacturing defect but no reported injuries or hospitalizations. Qualifies as risk-of-harm product where injury has not yet been reported per severity rubric, scoring 3 (High).
Plain-English summary
Preat Corp is recalling Astra EV-compatible 4.2mm Digital Analog medical devices (REF: 9006603 for single units and 9006603-10 for 10-packs). The recall affects 44 units.
The recall was initiated because of a manufacturing error in which the digital analog rotational feature is 180 degrees off from its correct position.
The affected devices were distributed nationwide to nine states: Alabama, California, Florida, Georgia, Kentucky, Maryland, Minnesota, New York, and Oklahoma. The affected lot numbers are 278735 and 278402.
Healthcare providers and facilities that may have received these devices are advised to verify whether they received units from the affected lots and to contact Preat Corp for further information and appropriate action.
The recalled product
- Product
- Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
- Manufacturer
- Preat Corp
- Category
- Medical Device
- Hazard
- rotational-defect
- manufacturing-error
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 (2)
- Lots: 278735
- & 278402/UDI:
Distribution
Distributed nationwide across the United States.
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