FDA (Devices) recall action 66351

Smiths Medical ASD, Inc. recalled 9 products on 2013-11-13

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2013-11-13
Critical: 0
Units: 7,549

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

ModerateFDA (Devices)··2013-11-13
Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination
Smiths Medical is recalling Portex Spinal Trays because visual particulate was found in the lidocaine and dextrose ampules.
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 p
Category
Distribution
39 states
HighFDA (Devices)··2013-11-13
Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination
Smiths Medical is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.
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, lumb
Category
Distribution
39 states
SevereFDA (Devices)··2013-11-13
Smiths Medical Recalls Portex Spinal Trays with Visual Particulate in Ampules
Smiths Medical ASD, Inc. is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection.
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 pu
Category
Distribution
39 states
HighFDA (Devices)··2013-11-13
Smiths Medical Recalls Portex Spinal Trays Due to Visual Particulates
Smiths Medical is recalling Portex Spinal Anaesthesia Trays because visual particulates were found in the included Lidocaine and Dextrose ampules.
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/spina
Category
Distribution
39 states
ModerateFDA (Devices)··2013-11-13
Smiths Medical Recalls Portex Spinal Trays Due to Visual Particulate
Smiths Medical ASD, Inc. is recalling 140 Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.
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, nerv
Category
Distribution
39 states
ModerateFDA (Devices)··2013-11-13
Smiths Medical Recalls Portex Regional Anesthesia Trays with Visual Particulates
Smiths Medical is recalling Portex Regional Anesthesia Trays because visual particulates were found in the included Lidocaine and Dextrose ampules.
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 pu
Category
Distribution
39 states
HighFDA (Devices)··2013-11-13
Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination
Smiths Medical ASD, Inc. is recalling Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.
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 p
Category
Distribution
39 states
HighFDA (Devices)··2013-11-13
Portex Spinal Trays Recalled Due to Visual Particulate in Lidocaine Ampules
Smiths Medical ASD is recalling 73 Portex Spinal Trays because visual particulate was found in the included Lidocaine HCL ampules.
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, lumba
Category
Distribution
39 states
ModerateFDA (Devices)··2013-11-13
Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination
Smiths Medical is recalling Portex Spinal Anaesthesia Trays because some included glass ampules contain visual particulate matter.
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, lumba
Category
Distribution
39 states