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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Medical

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  Class 2 Device Recall Smiths Medical see related information
Date Initiated by Firm July 10, 2013
Date Posted January 08, 2014
Recall Status1 Terminated 3 on September 15, 2021
Recall Number Z-0643-2014
Recall Event ID 67034
510(K)Number K063755  
Product Classification Syringe, antistick - Product Code MEG
Product Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in
Reference: 4429-3

Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
Code Information Lot Number: 2357318
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact
603-352-3812
Manufacturer Reason
for Recall		 Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes
FDA Determined
Cause 2		 Storage
Action The firm, Smiths Medical, sent an "URGENT FIELD SAFETY NOTICE" dated July 10, 2013 to its consignees/customers and distributors. The notice described the product, problem and actions to be taken. The Distributors were instructed to notify their customers. The consignees/customers were instructed to inspect your inventory for the suspect lots and remove all affected devices from use and complete and return the Urgent Field Safety Notice Confirmation Form by fax to 603-358-1017 or by email to FNS@smiths-medical.com within five (5) days of receipt of this notice. If you or your facility has distributed these affected products to other persons or facilities, please promptly forward the recipients of this Urgent Field Safety Notice. Upon receipt of the completed form, a customer service representative will contact you to arrange for exchange of your unused affected devices for credit or replacement. If you should have any questions regarding this information, please contact Smiths Medical's Customer Service Department at 800-258-5361
Quantity in Commerce 93700
Distribution Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = MEG and Original Applicant = SMITHS MEDICAL ASD, INC.
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