Recall Z-3202-2018 ยท FMF Syringe, Piston
ShinChang Medical Co., Ltd.
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.)
| Date | Aug 24, 2018 |
| Status | Terminated |
| Reason | Defect consists of a small crack in the top end of the barrel near the needle. |
| Root cause | Under Investigation by firm |
| Action | 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 ph |
| Quantity | 6,570,800 |
| Distribution | FL, TN, and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993017 | PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE Shinchang Medical Co., Ltd., Feb 25, 2000 |