Recall Z-0635-2024 ยท JXG Shunt, Central Nervous System And Components
Natus Medical Incorporated
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
| Date | Jan 4, 2024 (initiated Nov 28, 2023) |
| Status | Open, Classified |
| Reason | Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. |
| Root cause | Process change control |
| Action | 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 Re |
| Quantity | 3,336 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162437 | Codman EDS3 CSF External Drainage System Codman & Shurtleff, Inc., Oct 28, 2016 |