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U.S. Department of Health and Human Services

Class 2 Device Recall HEB InControl Insulin Syringe

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  Class 2 Device Recall HEB InControl Insulin Syringe see related information
Date Initiated by Firm January 19, 2018
Date Posted November 18, 2022
Recall Status1 Completed
Recall Number Z-0266-2023
Recall Event ID 91083
510(K)Number K191531  
Product Classification Syringe, piston - Product Code FMF
Product InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC
Code Information UDI/Lot/Expiration: 00041220791484/ 170407/ 2022-03-31
Recalling Firm/
Manufacturer		 Allison Medical, Inc.
8091 Shaffer Pkwy
Littleton CO 80127-3716
Manufacturer Reason
for Recall		 Insulin syringe retail packages incorrectly labeled as "Short Needle".
FDA Determined
Cause 2		 Error in labeling
Action On 01/19/2018, The recalling firm notified their customer of the recall.
Quantity in Commerce 1,500 Boxes (150,000 syringes)
Distribution Texas
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.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = Shina Med Corporation
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