Device product
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
Z-1733-2019
Product summary
- Event
- Event 82503
- Status
- Terminated
- Classification
- Class II
- Quantity
- 109000 (96,000 USA)
- Official record key
device-enforcement:Z-1733-2019
Official wording
Reason: Incorrect needle length and gage.
Code information: Item # 402010 Lot # 3707576
Distribution pattern: US Nationwide Distribution - AZ, CA, FL, GA, IL, IN, MA, MN, MO, MS, NJ, NY, PA, RI, SC, TN, TX, VA, and WA.
Derived failure modes
-
Unknown
Incorrect needle length and gage.