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Recall Observatory FDA recall evidence

Device 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.

Z-0644-2014

July 10, 2013

Class II

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 67034
Status
Terminated
Classification
Class II
Quantity
506925
Official record key
device-enforcement:Z-0644-2014

Official wording

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

Code information: Lot Numbers: 2330832, 2336493, 2348708, 2353094, 2357319

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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate