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U.S. Department of Health and Human Services

Class 2 Device Recall Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA

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 Class 2 Device Recall Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CAsee related information
Date Initiated by FirmApril 04, 2017
Create DateJuly 03, 2017
Recall Status1 Terminated 3 on August 05, 2019
Recall NumberZ-2670-2017
Recall Event ID 77402
510(K)NumberK923127 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductJelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
Code Information 3297460,3297461 Model No. EL1915.  3297458,3297459,3297465, 3297466,3297467 Model No. SB5021.
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer Reason
for Recall		Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro needles, Smiths Medical part numbers EL 1915 and SB5021.
FDA Determined
Cause 2		Process control
ActionSmiths Medical sent an "Urgent Medical Device Recall Notice" dated April 04, 2017. The letter was addressed to Quality Assurance Manager & Associate Sourcing Consultant. The letter listed the Affected devices described the Reason for Recall, & Risk to Health. Requested consignee to complete Urgent Medical Device Recall Response Form within 10 days of receipt and send it to: fieldactions@smithsmedical.com. For further questions, please call (603) 352-3812
Quantity in Commerce736,000
DistributionUS Distribution to the state of : IN
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMI
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