Gumi, N/A, Korea (the Republic of)
ShinChang Medical Co., Ltd. recalls
1 recall recorded since 2018, most recently on 24 August 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 24 August 2018
- Terminated
- 4 January 2023
- Reason
- Defect consists of a small crack in the top end of the barrel near the needle.
- Distribution
- FL, TN, and VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3202-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.