Recall Z-0644-2014
Smiths Medical ASD, Inc. · initiated July 10, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 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.
Codes / lots: Lot Numbers: 2330832, 2336493, 2348708, 2353094, 2357319
Reason for recall
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
FDA-determined cause: Storage
Action taken
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
Details
- Recall number
- Z-0644-2014
- Initiated
- July 10, 2013
- Posted by FDA
- January 8, 2014
- Terminated
- September 15, 2021
- Product code
- MEG – Syringe, Antistick
- Quantity
- 506925
- 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.
- Recalling firm
- Smiths Medical ASD, Inc., Keene, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0642-2014 Class II | Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2…Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin… | 07/10/2013Terminated |
| Z-0643-2014 Class II | Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2…Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin… | 07/10/2013Terminated |
| Z-0645-2014 Class II | Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2…Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin… | 07/10/2013Terminated |
| Z-0646-2014 Class II | Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2…Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin… | 07/10/2013Terminated |