Z-1733-2019Class II

Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile

Name: Z-1733-2019 Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile
Creator: Smiths Medical ASD Inc.
Published: 2019-02-11
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-02-11 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for... on 2019-02-11. FDA classified it as Class II and gives the reason as "Incorrect needle length and gage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1733-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-11
Posted: 2019-06-04
Terminated: 2020-06-23
Recalling firm: Abbott Medical
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.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Incorrect needle length and gage.
Root cause tag: manufacturing process
FDA root cause: Employee error
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]."
Quantity in commerce: 109000 (96,000 USA)
Distribution: US Nationwide Distribution - AZ, CA, FL, GA, IL, IN, MA, MN, MO, MS, NJ, NY, PA, RI, SC, TN, TX, VA, and WA.
Product codes and lots: Item # 402010 Lot # 3707576

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1733-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1733-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04

Product code FMI

K041399Class IIHypodermic Needle-Pro Edge Needle Protection DeviceSmiths Medical Asd, Inc. / cleared 2004-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)