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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Insulin Syringe 0.3mL

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  Class 2 Device Recall Disposable Insulin Syringe 0.3mL see related information
Date Initiated by Firm August 24, 2018
Create Date September 20, 2018
Recall Status1 Terminated 3 on January 04, 2023
Recall Number Z-3202-2018
Recall Event ID 80944
510(K)Number K993017  
Product Classification Syringe, piston - Product Code FMF
Product Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16.
(10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)
Code Information GNP Insulin Syringe 0.3mL 31G¿5/16" NP18127, Healthmart Insulin Syringe 0.3mL 31G¿5/16" NP18155,  Healthmart Insulin Syringe 0.3mL 31G¿5/16" NP18186,  Kroger Insulin Syringe 0.3mL 30G¿5/16" NP18082, Kroger Insulin Syringe 0.3mL 31G¿5/16" NP18083, Kroger Insulin Syringe 0.3mL 30G¿5/16" NP18126, Kroger Insulin Syringe 0.3mL 30G¿5/16" NP18146, Kroger Insulin Syringe 0.3mL 31G¿5/16" NP18157, Leader Insulin Syringe 0.3mL 31G¿5/16" NP18123, Leader Insulin Syringe 0.3mL 31G¿5/16" NP18130, Leader Insulin Syringe 0.3mL 30G¿5/16" NP18151, Leader Insulin Syringe 0.3mL 31G¿5/16" NP18161, Leader Insulin Syringe 0.3mL 30G¿5/16" NP18180, Leader Insulin Syringe 0.3mL 31G¿5/16" NP18202, Nipro Insulin Syringe 0.3mL 31G¿5/16" NP18125. Nipro Insulin Syringe 0.3mL 30G¿5/16" NP18129. Nipro Insulin Syringe 0.3mL 31G¿5/16" NP18142. Nipro Insulin Syringe 0.3mL 31G¿5/16" NP18170. Nipro Insulin Syringe 0.3mL 29G¿1/2" NP18196. Nipro Insulin Syringe 0.3mL 30G¿5/16" NP18197. Nipro Insulin Syringe 0.3mL 30G¿5/16" NP18199. Sunmark Insulin Syringe 0.3mL 31G¿5/16" NP18124, Sunmark Insulin Syringe 0.3mL 30G¿5/16" NP18128, Sunmark Insulin Syringe 0.3mL 31G¿5/16" NP18136, Sunmark Insulin Syringe 0.3mL 31G¿5/16" NP18166,  Sunmark Insulin Syringe 0.3mL 30G¿5/16" NP18206,  Lite Touch Insulin Syringe 0.3mL 30G¿5/16" LT1805, and  McKesson Insulin Syringe 0.3mL 31G¿5/16" KSH0603.             
Recalling Firm/
Manufacturer		 ShinChang Medical Co., Ltd.
144 1gongdan-Ro
Gumi Korea (the Republic of)
Manufacturer Reason
for Recall		 Defect consists of a small crack in the top end of the barrel near the needle.
FDA Determined
Cause 2		 Under Investigation by firm
Action The company has been requesting that the importers immediately cease all distribution of affected Lot Numbers and notify its customers to do the same. The customers shall include wholesale distributors, retail pharmacies and mail order pharmacies or patients. The customer who received the affected products shall quarantine. The customers may return the affected products and the company will replace. Any and all questions pertaining to the recall and disposition of recalled product can be addressed to Yushin Kim, CEO ShinChang Medical Co.,Ltd. By email at yushin0229@scmedical.co.kr or by phone at +82-54-463-2400
Quantity in Commerce 6,570,800
Distribution FL, TN, and VA
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 = FMF and Original Applicant = SHIN CHANG MEDICAL CO., LTD.
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