External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Summary
The FDA issued a Class II for External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only by Natus Medical Incorporated. Reason: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing..
Details
Source
Device Recall
External ID
Z-0634-2024
Action Date
2024-01-10
Status
Ongoing
Category
device
Product Description
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Lot/Code Info: UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455
Quantity Affected: 2,686 units
Reason for Recall
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-28
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 84 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Natus Medical Incorporated has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Natus Medical Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Natus Medical Incorporated have FDA actions?
Natus Medical Incorporated has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0634-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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