Recall Z-3202-2018— ShinChang Medical Co., Ltd.

Name: FDA recall Z-3202-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-24

Class II · Terminated

Class II FDA medical device recall by ShinChang Medical Co., Ltd., initiated 2018-08-24, terminated 2023-01-04. It names one FDA 510(k) clearance: K993017. 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: Defect consists of a small crack in the top end of the barrel near the needle..

Recalling firm: ShinChang Medical Co., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2018-08-24
Terminated: 2023-01-04
Firm location: Gumi, N/A, Korea (the Republic of)

510(k) clearances named in this recall

1 on FDA's record

K993017 — PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGEShinchang Medical Co., Ltd.·cleared 2000-02-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.