San Diego, CA, United States
Natus Medical Incorporated recalls
2 recalls recorded since 2018, most recently on 28 November 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 November 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0635-2024, Z-0634-2024
- EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
- External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Ongoing Class II Medical devices
- Recall started
- 18 November 2022
- Reason
- Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.
- Distribution
- U.S. Nationwide distribution in the states of AK, CA, CT, DC, FL, GA, IA, ID, IL, KS , MD, MI, MT, ND, NE, NJ, NV, NY, OH, OR, TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0735-2023
- The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculo
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.