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U.S. Department of Health and Human Services

Class 2 Device Recall VGO "No Needle Demo Unit"

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 Class 2 Device Recall VGO "No Needle Demo Unit"see related information
Date Initiated by FirmJuly 03, 2019
Create DateOctober 26, 2019
Recall Status1 Terminated 3 on June 24, 2020
Recall NumberZ-0197-2020
Recall Event ID 83386
510(K)NumberK103825 
Product Classification Pump, infusion, insulin - Product Code LZG
ProductDEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Code Information UDI: (01)10385609020015(17)XXXXXX(10)XXXXXXXX  Lot Numbers: DM418011 DM418012 DM418013  DM418014 DM418015 DM418016 DM418017 DM418031 DM418033 DM418037   
Recalling Firm/
Manufacturer		 Valeritas, Incorporated
293 Boston Post Rd W Ste 330
Marlborough MA 01752-4615
For Additional Information Contact
908-927-9920
Manufacturer Reason
for Recall		There is a potential for "No Needle Demo Units" to contain a needle.
FDA Determined
Cause 2		Employee error
ActionOn July 3, 2019, Valeritas issued notices to customers via first class U.S. postal service. The removal strategy is to notify active HCP office accounts from the manufacturing start date of effected product (January 2018) who may have No Needle Demo units in their possession. The removal letter instructs HCP offices to dispose of any No Needle Demo product on hand and acknowledgement by signing and returning the removal letter as instructed.
Quantity in Commerce21,714 devices
DistributionNationwide within U.S.
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 = LZG
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