Reported Jan 10, 2024 · Ongoing
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Natus Medical Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Natus Medical Incorporated · 5955 Pacific Center Blvd · San Diego, CA · 92121-4309
Is this the product you have?
- External Drainage System Collection Bag
- REFNT821732C, STERILEEO, Rx only
- Lot codes and dates
- UDI00382830050562/ Lot #:
1FX00049516601FX00049516581FX00049516591FX00050404501FX00050404511FX00050404521FX00050404531FX00050404541FX00050404571FX00050404561FX00050796961FX00051264751FX00051264741FX0005040455
- UDI00382830050562/ Lot #:
- Amount recalled
- 2,686 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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