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U.S. Department of Health and Human Services

Class 2 Device Recall Spinal Anesthesia Trays

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 Class 2 Device Recall Spinal Anesthesia Trayssee related information
Date Initiated by FirmSeptember 23, 2013
Date PostedNovember 05, 2013
Recall Status1 Terminated 3 on August 22, 2016
Recall NumberZ-0156-2014
Recall Event ID 66351
Product Classification Anesthesia conduction kit - Product Code CAZ
ProductPortex 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.
Code Information Lot Number: 2440516
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact
800-258-5361
Manufacturer 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.
FDA Determined
Cause 2
Material/Component Contamination
ActionSmiths 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 spinal@smiths-medical.com. 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 Commerce140
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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