Drug recall
Portex¿ Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthesia family of products is comprised…
FDA recall event 66351 · Class II · Smiths Medical ASD, Inc.
Key facts
| Event ID | 66351 |
|---|---|
| Recall numbers | Z-0156-2014, Z-0157-2014, Z-0158-2014, Z-0159-2014, Z-0160-2014, Z-0161-2014, Z-0162-2014, Z-0163-2014, Z-0164-2014 |
| Recalling firm | Smiths Medical ASD, Inc. |
| Product type | Devices |
| Products | 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…, 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)…, 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…, 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…, 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… and 4 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 23, 2013 |
| Report date | Nov 13, 2013 |
| Termination date | Aug 22, 2016 |
| City | Keene |
| State | NH |
| Country | United States |
| FEI number | 1217052 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: