CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report

Portex¿ Spinal Tray with Drugs Whitacre/ Whitacre recalled

Smiths Medical ASD is recalling Portex¿ Spinal Tray with Drugs Whitacre/ Whitacre, distributed nationwide in the US. The recall was initiated on 23 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 2440516

Quantity recalled140

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-0156-2014
FDA event ID: 66351
Recalling firm: Smiths Medical ASD, Keene, NH
Classification: Class II
Status: Terminated
Recall initiated: 23 Sep 2013
FDA classified: 5 Nov 2013
Reported: 13 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Heart & Vascular Devices

Timeline

23 Sep 2013	Recall initiated by company
5 Nov 2013	Classified by FDA	+43 days
13 Nov 2013	Published in enforcement report	+8 days

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

Reason for recall

Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays.

Product as listed by the FDA

Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.

Where it was distributed

Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.

Nationwide Alaska Arkansas Arizona California Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Number: 2440516

Where was it sold?

Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.

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

Other products in this recall event

8 other products · FDA event 66351

This product is part of a recall event; the main page for the event is Portex¿ Spinal Tray with Drugs Whitacre recalled by Smiths Medical ASD.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2013	CLASS II	Portex¿ Spinal Tray with Drugs Whitacre recalled by Smiths Medical ASD	Smiths Medical ASD	Particulate Matter	Nationwide
13 Nov 2013	CLASS II	Portex¿ Saddleblock Tray with Drugs Quincke recalled	Smiths Medical ASD	Particulate Matter	Nationwide
13 Nov 2013	CLASS II	Portex¿ Spinal Tray with Drugs Whitacre recalled by Smiths Medical ASD	Smiths Medical ASD	Particulate Matter	Nationwide
13 Nov 2013	CLASS II	Portex¿ Saddleblock Tray with Drugs Quincke (Without Introducer) recalled	Smiths Medical ASD	Particulate Matter	Nationwide
13 Nov 2013	CLASS II	Portex¿ Spinal Tray with Drugs Whitacre recalled by Smiths Medical ASD	Smiths Medical ASD	Particulate Matter	Nationwide
13 Nov 2013	CLASS II	Portex¿ Spinal Tray with Drugs Quincke recalled by Smiths Medical ASD	Smiths Medical ASD	Particulate Matter	Nationwide
13 Nov 2013	CLASS II	Portex¿ Saddleblock Tray with Drugs Quincke recalled	Smiths Medical ASD	Particulate Matter	Nationwide
13 Nov 2013	CLASS II	Portex¿ Regional Anesthesia Tray with Drugs recalled	Smiths Medical ASD	Particulate Matter	Nationwide

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