medical Class II Updated 2018-09-26

ShinChang Medical Co., Ltd. recalls Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/

Recalled 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.)

Hazard / Issue

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

Issued by

FDA

Affected States: FL, TN, VA
Lot/Code Info: 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.
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