Z-1733-2019 Class II Terminated
FDA device recall Z-1733-2019 was initiated by Smiths Medical ASD Inc. on February 11, 2019 and is designated Class II. Reason for recall: Incorrect needle length and gage. The recall status is terminated (terminated June 23, 2020). Affected quantity: 109000 (96,000 USA).
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- February 11, 2019
- Termination Date
- June 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 109000 (96,000 USA)
Product 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 for Recall
Incorrect needle length and gage.
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.
Code Information
Item # 402010 Lot # 3707576