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U.S. Department of Health and Human Services

Class 1 Device Recall JELCO HYPODERMIC NEEDLEPRO FIXED NEEDLE INSULIN SYRINGE

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  Class 1 Device Recall JELCO HYPODERMIC NEEDLEPRO FIXED NEEDLE INSULIN SYRINGE see related information
Date Initiated by Firm May 17, 2021
Date Posted June 10, 2021
Recall Status1 Terminated 3 on October 11, 2023
Recall Number Z-1798-2021
Recall Event ID 87945
510(K)Number K063755  
Product Classification Syringe, antistick - Product Code MEG
Product JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE:
a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1
b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
Code Information a) REF 4428-1, Lot Numbers: 4046543 and 4062235 b) REF 4429-1, Lot Numbers: 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238, 4062242, 4014096 
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Dave Halverson
763-383-3310
Manufacturer Reason
for Recall		 Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall on May 17, 2021 by email. The firm is seeking the removal of the product down to the consumer level. For assistance ease contact Novasyte using the Email: smithsmedical-Jelco2021@novasyte.com The firm later realized they failed to include lot #40140906 for model #4429-1 and issued a second letter which was dated 5/27/2021 to customers involved in the first notification where this lot was excluded in the letter, as well as to new consignees who received the affected lot.
Quantity in Commerce 1,432,200 units
Distribution Worldwide distribution - US Nationwide and the countries of UK, Spain.
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 = MEG and Original Applicant = SMITHS MEDICAL ASD, INC.
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