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U.S. Department of Health and Human Services

Class 2 Device Recall Smith Medical JELCO Hypodermic NeedlePro EDGE Safety Device Safety Device Rx Only Sterile

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  Class 2 Device Recall Smith Medical JELCO Hypodermic NeedlePro EDGE Safety Device Safety Device Rx Only Sterile see related information
Date Initiated by Firm February 11, 2019
Create Date June 04, 2019
Recall Status1 Terminated 3 on June 23, 2020
Recall Number Z-1733-2019
Recall Event ID 82503
510(K)Number K041399  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
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.
Code Information Item # 402010 Lot # 3707576
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer Reason
for Recall		 Incorrect needle length and gage.
FDA Determined
Cause 2		 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 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."
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = SMITHS MEDICAL ASD, INC.
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