The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck

Reason: Due to an uptick of complaints associated with premature needle retraction of blood collection system.

Code information: Model Number/Part Number/Description: 2700-21-EN/P00157-001/Steripath Gen2 Blood Collection System - 21G, Wide Neck UDI Sales Pack: 10858366007013 UDI Sterile Pack: 00858366007016 Lot Numbers: 9447412 9447043 9446903 9447120 9446991 9447413 2700-23-EN/P00158-001/Steripath Gen2 Blood Collection System - 23G, Wide Neck UDI Sales Pack: 10858366007020 UDI Sterile Pack: 00858366007023 Lot Numbers: 9446807 9447124 5005432 9446708 9447121 27BD-21-EN/P00166-000/Steripath Gen2 Blood Collection System - 21G, Long Neck UDI Sales Pack: 10858366007037 UDI Sterile Pack: 00858366007030 Lot Numbers: 5005328 9446696 9446547 9446994 27BD-23-EN/P00167-000/Steripath Gen2 Blood Collection System - 23G, Long Neck UDI Sales Pack: 10858366007044 UDI Sterile Pack: 00858366007047 Lot Numbers: 9447122

Distribution pattern: U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.