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 Recall Z-1733-2019 · Posted None
Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2019-02-11
Date Terminated2020-06-23
Product Quantity109000 (96,000 USA)
Reason for Recall
Incorrect needle length and gage.
Firm Action
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 [email protected], 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 [email protected]."
Root Cause
Employee error
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.