—#124582

Product

Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN 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.

FDA product code: MEG — Syringe, Antistick
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K063755
Affected lot / code info: Lot Numbers: 2356156, 2358706

Why it was recalled

Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes

Root cause (FDA determination)

Storage

Action the firm took

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

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-07-10
Posted by FDA: 2014-01-08
Terminated: 2021-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124582. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.