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.)
Recall
- Recall Number
- Z-3202-2018
- Event Number
- 80944
- Firm
- ShinChang Medical Co., Ltd. 144 1gongdan-Ro Gumi Korea (the Republic of)
- FEI Number
- 3003169040
- Product Code
- FMF
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- August 24, 2018
- Terminated
- January 4, 2023
Description
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.)
Defect consists of a small crack in the top end of the barrel near the needle.
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 [email protected] or by phone at +82-54-463-2400
FL, TN, and VA
6,570,800