Smiths Medical ASD, Inc.: 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.

Agency Publication Date: November 5, 2013

Affected Products

Product: 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.

Lot Number: 2440516

Lot Numbers:

Number

Product: Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 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.

Lot Number: 2445601

Lot Numbers:

Number

Product: Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 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.

Lot Number: 2440517

Lot Numbers:

Number

Product: 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.

Lot Number: 2450807

Lot Numbers:

Number

Product: Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 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.

Lot: 2445604, 2440523, 2445605, 2445606, 2450812

Lot Numbers:

2445604

Product: Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-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.

Lot: 2426443, 2431124, 2440524, 2450808

Lot Numbers:

2426443

Product: Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 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.

Lot: 2445619

Lot Numbers:

2445619

Product: Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 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.

Lot: 2450793

Lot Numbers:

2450793

Product: Portex¿ Saddleblock Tray with Drugs 25g Quincke; 4795-20 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.

Lot: 2455104

Lot Numbers:

2455104

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66351

Status: Resolved

Manufacturer: Smiths Medical ASD, Inc.

Manufactured In: United States

Units Affected: 9 products (140; 73; 830; 100; 3980; 1904; 100; 200; 222)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Number: 2440516

Lot Numbers:

Number

Lot Number: 2445601

Lot Numbers:

Number

Lot Number: 2440517

Lot Numbers:

Number

Lot Number: 2450807

Lot Numbers:

Number

Lot: 2445604, 2440523, 2445605, 2445606, 2450812

Lot Numbers:

2445604

Lot: 2426443, 2431124, 2440524, 2450808

Lot Numbers:

2426443

Lot: 2445619

Lot Numbers:

2445619

Lot: 2450793

Lot Numbers:

2450793

Lot: 2455104

Lot Numbers:

2455104