Recall Z-0634-2024
Natus Medical Incorporated · initiated November 28, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Codes / lots: UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455
Reason for recall
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
FDA-determined cause: Process change control
Action taken
On November 28, 2023, Natus issued a "Urgent Medical Device Recall" Notification to affected consignees via USPS. Natus asked consignees to take the following actions: 1. Immediately cease use of the affected System and quarantine any inventory until you receive the shipping instructions from Natus to return any System(s). 2) Please complete the enclosed form and return to FCA@Natus.com. You will receive shipping instructions from FCA@Natus.com 3) Adverse reactions or quality problems experienced with the use of the System should be reported to Natus and the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report Online at www.fda.gov/medwatch/report.htm " Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 4) Replacement System(s) will be made available to you at no cost. Natus Technical Service will be in contact with you shortly to arrange for the provision of replacement System(s).
Details
- Recall number
- Z-0634-2024
- Initiated
- November 28, 2023
- Posted by FDA
- January 4, 2024
- Product code
- JXG – Shunt, Central Nervous System And Components
- 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.
- Recalling firm
- Natus Medical Incorporated, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0635-2024 Class II | EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx onlySterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. | 11/28/2023Open, Classified |