Z-0163-2014Class II

Portex Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family...

Name: Z-0163-2014 Portex Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family...
Creator: Smiths Medical ASD, Inc.
Published: 2013-09-23
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-09-23 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Portex Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised of sterile (unless... on 2013-09-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0163-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-23
Posted: 2013-11-05
Terminated: 2016-08-22
Recalling firm: Abbott Medical
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.
Product code: CAZ Anesthesia Conduction Kit
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Smiths Medical sent an Urgent Recall Notice dated September 23, 2013, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and remove from use. Complete the Confirmation Form and return by fax to 603-358-1017 or by email to [email protected]. Upon receipt of the completed form, a customer service representative would contact them to arrange for exchange of their unused affected devices for credit or replacement. Customers were also instructed to forward the notice to all personnel who need to be aware within their organization. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at 800-258-5361. For questions regarding this recall call 800-258-5361.
Quantity in commerce: 200
Distribution: 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.
Product codes and lots: Lot: 2450793

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0163-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0156-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05
Z-0157-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05
Z-0158-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05
Z-0159-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05
Z-0160-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05
Z-0161-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05
Z-0162-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05
Z-0163-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05
Z-0164-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05

Product code CAZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)