Medtronic Neurosurgery: Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a

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: 3, 889 units Lot/code info: Lot Number/GTIN: 222277587 00613994445407; 223565027 00763000624804; 223580362 00763000624804; 223698572 00763000624804; 223734523 00763000624804; 223999040 00763000406028; 224301720 00763000406028; 224302820 00613994445407; 224973997 00613994445407; 224990852 00613994445407; 224990870 00613994445407; 224990871 00613994445407; 225198822 00613994445407; 226490967 00763000624804; 226517899 00763000624804; 226546799 00613994445407; 226571115 00613994445407; 226665388 00763000624804; 226665395 00613994445407; 226734688 00763000624804; 226734689 00763000624804; 226756273 00763000406028

UPC codes

00613994445407, 00763000624804, 00763000406028

Source

Official record: FDA (Device enforcement) ↗

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