Smiths Medical ASD, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0159-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Portex¿ Regional Anesthesia Tray with Drugs; 15548-20 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.

Product Classification:

Class II

Date Initiated: September 23, 2013

Date Posted: November 13, 2013

Recall Number: Z-0159-2014

Event ID: 66351

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.

Status: Terminated

Product Quantity: 100

Code Information:

Lot Number: 2450807

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated