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 Ge
Check against the official notice below — it lists the full affected range.
Magnolia Medical Technologies, Inc. is recalling 137,200 Steripath Gen2 Blood Collection System devices distributed nationwide due to reports of premature needle retraction. The recalled devices include four models: the 21G and 23G Wide Neck versions (model numbers 2700-21-EN and 2700-23-EN) and the 21G and 23G Long Neck versions (model numbers 27BD-21-EN and 27BD-23-EN), with specific lot numbers identified for each model. These devices were distributed across 28 states including Maryland, California, Texas, Florida, New York, Pennsylvania, and others.
The source document does not specify a remedy or what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
Reason for recall: Due to an uptick of complaints associated with premature needle retraction of blood collection system. Distribution: 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. Quantity: 137,200 devices Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.