Device product
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 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-0642-2014
Product summary
- Event
- Event 67034
- Status
- Terminated
- Classification
- Class II
- Quantity
- 363015
- Official record key
device-enforcement:Z-0642-2014
Official wording
Reason: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes
Code information: Lot Numbers: 2340530, 2344163, 2353091, 2357317, 2377316
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
particulate