Reported Jun 17, 2015 · Terminated
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED…
Smiths Medical Asd 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: Smiths Medical Asd Inc · 6250 Shier Rings Rd · Dublin, OH · 43016-1270
Is this the product you have?
- Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
- Lot codes and dates
- Product Reorder Number
537235CLot #2761409
- Product Reorder Number
- Amount recalled
- 6,000 units
Where it was sold
Why it was recalled
Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.
This product could cause temporary or reversible health problems — stop using it.
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