CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report

Low Volume Extension Set, 72' w/Clamp Fll/Mll Apv=, Sterile recalled

Smiths Medical Asd is recalling Low Volume Extension Set, 72' w/Clamp Fll/Mll Apv=, Sterile, And Fluid Path Nonpyrogenic, distributed in Kentucky, Minnesota, New Jersey, Utah, Wisconsin. The recall was initiated on 4 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Reorder Number: 537235C; Lot #2761409

Quantity recalled6,000 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1730-2015
FDA event ID: 71142
Recalling firm: Smiths Medical Asd, Dublin, OH
Classification: Class II
Status: Terminated
Recall initiated: 4 May 2015
FDA classified: 8 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

4 May 2015	Recall initiated by company
8 Jun 2015	Classified by FDA	+35 days
17 Jun 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

Kentucky Minnesota New Jersey Utah Wisconsin

Questions about this recall

Is Low Volume Extension Set, 72' w/Clamp Fll/Mll Apv=, Sterile, And Fluid Path Nonpyrogenic recalled?

Yes. Smiths Medical Asd recalled Low Volume Extension Set, 72' w/Clamp Fll/Mll Apv=, Sterile, And Fluid Path Nonpyrogenic on 4 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1730-2015.

Why was it 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.

Which lots are affected?

Product Reorder Number: 537235C; Lot #2761409

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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