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Recall Observatory FDA recall evidence

Device product

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.

Z-1730-2015

May 04, 2015

Class II

Product summary

Firm
Smiths Medical Asd Inc
Event
Event 71142
Status
Terminated
Classification
Class II
Quantity
6,000 units
Official record key
device-enforcement:Z-1730-2015

Official wording

Reason: 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.

Code information: Product Reorder Number: 537235C; Lot #2761409

Distribution pattern: Distributed to the states of KY, MN, NJ, UT, & WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.