Medtronic Neurosurgery: Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce

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: 32,404 units Lot/code info: Lot Number/GTIN: 221482529 00763000395971; 221520718 00763000395971; 221648854 00763000395971; 221687765 00763000395971; 221744158 00763000395971; 221744549 00763000395971; 221795479 00613994445377; 221827827 00613994445377; 221827828 00613994445377; 221873427 00763000395971; 221873428 00763000395971; 221915124 00763000395971; 221915125 00763000395971; 221916163 00613994445377; 221916164 00763000395971; 221955230 00763000395971; 221955231 00763000395971; 222015665 00613994445377; 222061755 00613994445377; 222204094 00613994445377; 222345104 00613994445377; 222345105 00613994445377; 222346067 00613994445377; 222393929 00763000395971; 222393930 00763000395971; 222530273 00613994445377; 222543362 00763000395971; 222543363 00763000395971; 222580924 00613994445377; 222970856 00613994445377; 222970857 00613994445377; 222970858 00613994445377; 222999295 00613994445377; 222999296 00613994445377; 223070846 00763000395971; 223130156 00763000395971; 223165960 00763000395971; 223165961 00763000395971; 223165962 00763000395971; 223251949 00763000395971; 223580360 00763000624774; 223620063 00763000624774; 223621055 00763000624774; 223659559 00763000624774; 223659560 00763000624774; 223698571 00763000624774; 223734521 00763000624774; 223734522 00763000624774; 223778509 00763000624774; 223999041 00613994445377; 224032597 00763000624774; 224173197 00763000395971; 224342656 00763000395971; 224387139 00763000395971; 224852792 00763000624774; 224852793 00763000624774; 224852794 00763000624774; 2

UPC codes

00763000395971, 00613994445377, 00763000624774

Source

Official record: FDA (Device enforcement) ↗

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