External Drainage System Collection Bag recall: Sterility Concern
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Why was External Drainage System Collection Bag recalled?
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455
- Product
- External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
- Recalling firm
- Natus Medical Incorporated
- Quantity
- 2,686 units
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV.
- Recall date
- January 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)