EDS 3 CSF External Drainage System recalled for incomplete sterility testing
Natus Medical is recalling 3,336 units of the EDS 3 CSF External Drainage System nationwide because incomplete bioburden testing cannot guarantee sterility. No illnesses have been reported, but non-sterile devices pose infection risk.
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 medical device where sterility assurance cannot be guaranteed due to incomplete bioburden testing. The hazard is theoretical—no illnesses or injuries have been reported—but the product poses a risk of harm through potential infection if units are non-sterile, warranting a High severity rating.
Plain-English summary
Natus Medical Incorporated is recalling the EDS 3 CSF External Drainage System (reference number NT821731C, UDI 00382830050555) distributed nationwide. The recall is due to incomplete bioburden testing that prevents the manufacturer from guaranteeing sterility of all units.
The affected product is used in clinical settings for external drainage of cerebrospinal fluid in neurosurgical patients. Approximately 3,336 units have been distributed across all US states. Affected lot numbers include 1FX0004588937, 1FX0004588938, 1FX0004588939, and 48 additional lot codes as listed in the FDA recall notice.
Non-sterile drainage systems pose a risk of infection in patients requiring CSF drainage. No illnesses or injuries have been reported to date. Healthcare facilities should contact their device supplier or Natus Medical directly to arrange return or replacement of affected units and evaluate alternative products for current patient care needs.
Patients who have received these devices should consult their healthcare provider about appropriate monitoring and follow-up care if concerned about their treatment.
The recalled product
- Product
- EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
- Manufacturer
- Natus Medical Incorporated
- Hazard
- sterility-failure
- infection-risk
Distribution
Distributed nationwide across the United States.
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