FDAClass IIJanuary 15, 2014

Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed recall: Particulate Matter

Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN 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.

Why was Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 2358702

Product
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN 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.
Recalling firm
Smiths Medical ASD, Inc.
Quantity
54000
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.
Recall date
January 15, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls