Smiths Medical ASD, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0646-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 10, 2013

Date Posted: January 15, 2014

Recall Number: Z-0646-2014

Event ID: 67034

Reason for Recall:

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

Status: Terminated

Product Quantity: 54000

Code Information:

Lot Numbers: 2358702

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.

Voluntary or Mandated:

Voluntary: Firm initiated