FDA Enforcement
Class II
Terminated
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.
Recall: Z-1733-2019
·
Reported June 12, 2019
Enforcement
- Recall Number
- Z-1733-2019
- Event ID
- 82503
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Smiths Medical ASD Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 12, 2019
- Initiation Date
- February 11, 2019
- Classification Date
- June 4, 2019
- Termination Date
- June 23, 2020
- Address
- 6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States
Description
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.
Reason
Incorrect needle length and gage.
Code Info
Item # 402010 Lot # 3707576
Distribution
US Nationwide Distribution - AZ, CA, FL, GA, IL, IN, MA, MN, MO, MS, NJ, NY, PA, RI, SC, TN, TX, VA, and WA.
Quantity
109000 (96,000 USA)