—#171714

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.

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041399
Affected lot / code info: Item # 402010 Lot # 3707576

Why it was recalled

Incorrect needle length and gage.

Root cause (FDA determination)

Employee error

Action the firm took

On 2/11/2019 the firm sent notifications of the recall with the following instructions: " 1.Locate and determine the number of affected products in your possession 2.Complete the attached Response Form within 10 days and return it to fieldactions@smiths-medical.com, even if you do not have any of the affected product in your possession. 3.Return affected product to Smiths Medical utilizing the pre-paid shipping labels included with this notice include a copy of your completed Response Form inside EACH BOX of returned product to facilitate processing of credit or replacement. Ensure boxes are sealed and labeled with your facility name prior to shipping. 4.DISTRIBUTORS: If you have distributed potentially affected devices to your customers, please immediately notify them of this Field Safety Corrective Action. Smiths Medical is committed to providing quality products and service to its customers. We apologize for any inconvenience this situation may cause. If you have any questions regarding this notification, please contact Smiths Medical via email at fieldactions@smiths-medical.com."

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

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.

Timeline

Recall initiated: 2019-02-11
Terminated: 2020-06-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171714. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.