Reported Dec 8, 2021 · Terminated
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System…
Magnolia Medical Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Magnolia Medical Technologies, Inc. · 200 W Mercer St Ste 500 · Seattle, WA · 98119-5908
Is this the product you have?
- 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
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 1085836600701300858366007016Model 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 2 1085836600702000858366007023Lot 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 3 1085836600703700858366007030Lot 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 4 1085836600704400858366007047Lot 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 5 Lot Numbers: 9447122 - Amount recalled
- 137,200 devices
Where it was sold
Why it was recalled
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
This product could cause temporary or reversible health problems — stop using it.
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