Medtronic Neurosurgery: Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF)

Hazard

Potential for catheter disconnection from the patient line stopcock connectors.

Details from the source

Reason for recall: Potential for catheter disconnection from the patient line stopcock connectors. Distribution: Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and OUS (foreign): Argentina, Australia, Bahrain, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cur Quantity: 11,840 units Lot/code info: Lot Number/GTIN: 221343119 00613994445391; 221612695 00613994445391; 221873429 00613994445391; 221873431 00763000406011; 222082062 00613994445391; 222480771 00763000406011; 222480772 00763000406011; 223565026 00763000624798; 223580361 00763000624798; 223580378 00763000624798; 223618474 00763000624798; 223621056 00763000624798; 223659561 00763000624798; 223907224 00613994445391; 223907225 00613994445391; 223956150 00613994445391; 223999042 00613994445391; 223999043 00613994445391; 224032609 00613994445391; 224128508 00763000406011; 224387126 00763000406011; 224852795 00613994445391; 224852796 00613994445391; 224878536 00613994445391; 224949834 00613994445391; 224949835 00613994445391; 224990657 00763000624798; 224990660 00613994445391; 224990846 00613994445391; 224990847 00763000624798; 224990889 00763000624798; 225198821 00613994445391; 225500036 00613994445391; 225500037 00613994445391; 225675930 00763000406011; 225675932 00613994445391; 225686835 00613994445391; 225749841 00763000406011; 226111239 00613994445391; 226242273 00763000624798; 226288883 00763000624798; 226335146 00613994445391; 226335147 00763000624798; 226335148 00613994445391; 226366036 00763000624798; 226420635 00763000406011; 226420636 00763000624798; 226517902 00613994445391; 226567491 00763000624798; 226616245 00763000624798; 226734637 00763000624798; 226734639 00763000624798; 226734641 00763000624798; 226734643 00763000624798; 226734645 00763000624798; 226734686 00763000624798; 226756274 00613994445391; 2

UPC codes

00613994445391, 00763000406011, 00763000624798

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.