Device product
Langston Dual Lumen Catheter
Z-0110-2021
Product summary
- Event
- Event 86433
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1,680 units
- Official record key
device-enforcement:Z-0110-2021
Official wording
Reason: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Code information: Model Number: 5515, UDI 10841156100506 Lot Numbers: 635806, 640206, 644140, 648701, 654143, 658252, 659635, 661470, 665301, 670376, 654130, 672728, 656020, 638111, 677058.
Distribution pattern: Domestic Distribution: AK, 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 WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.
Derived failure modes
-
Unknown
The inner lumen of the Langston catheter may separate from the hub during pressure injection.