FDA Device

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.)

Hazard

Defect consists of a small crack in the top end of the barrel near the needle.

What You Should Do

Remedy

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

Products

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
Brand
ShinChang Medical Co., Ltd. 144 1gongdan-Ro Gumi Korea (the Republic of)
UPC
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.

Units Affected

6,570,800