Z-0645-2014Class II

Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by...

Name: Z-0645-2014 Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by...
Creator: Smiths Medical ASD, Inc.
Published: 2013-07-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-07-10 / Terminated

FDA source

Smiths Medical ASD, Inc. began a recall of 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... on 2013-07-10. FDA classified it as Class II and gives the reason as "Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0645-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-10
Posted: 2014-01-08
Terminated: 2021-09-15
Recalling firm: Abbott Medical
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.
Product code: MEG Syringe, Antistick
Reason for recall: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
FDA root cause: 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 [email protected] 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: 108000
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.
Product codes and lots: Lot Numbers: 2356156, 2358706

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0645-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0642-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-08
Z-0643-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-08
Z-0644-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-08
Z-0645-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-08
Z-0646-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-08

Product code MEG

K063755Class IIPortex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. / cleared 2007-02-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)