FDA recall Z-3202-2018

ShinChang Medical Co., Ltd. · Class II · device

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.)

Reason for recall

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

Distribution

FL, TN, and VA

Key facts

Status
Terminated
Initiation date
2018-08-24
Report date
2018-09-26
Termination date
2023-01-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gumi, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3202-2018