External Drainage System Collection Bags Recalled for Sterility Assurance Issues
Natus Medical Incorporated is recalling 2,686 units of External Drainage System Collection Bags due to incomplete bioburden testing that prevents sterility assurance. Healthcare facilities and patients should contact the manufacturer or their healthcare provider for guidance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II recall without reported illnesses or injuries. The hazard—inability to guarantee sterility due to incomplete bioburden testing—represents a risk of harm to patients with no actual adverse events documented, placing it in the High category per the rubric.
Plain-English summary
Natus Medical Incorporated has recalled 2,686 units of External Drainage System Collection Bags (REF: NT821732C, STERILE, Rx only) due to incomplete bioburden testing that prevents the manufacturer from guaranteeing sterility assurance. The product is distributed nationwide across the United States.
The affected lot numbers are: 1FX0004951660, 1FX0004951658, 1FX0004951659, 1FX0005040450, 1FX0005040451, 1FX0005040452, 1FX0005040453, 1FX0005040454, 1FX0005040457, 1FX0005040456, 1FX0005079696, 1FX0005126475, 1FX0005126474, and 1FX0005040455. The UDI is 00382830050562.
Healthcare facilities and patients who have received this product should contact Natus Medical Incorporated or their healthcare provider for further instructions. No illnesses or injuries have been reported in connection with this product.
The recalled product
- Product
- External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
- Manufacturer
- Natus Medical Incorporated
- Affected units
- 2,686
Distribution
Part of a larger recall action
This product is one of 2 recalled by Natus Medical Incorporated 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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