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.)
FDA Recall Z-3202-2018 · Posted None
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Recalling FirmShinChang Medical Co., Ltd.
Recall StatusTerminated
Product CodeFMF
Date Initiated2018-08-24
Date Terminated2023-01-04
Product Quantity6,570,800
Reason for Recall
Defect consists of a small crack in the top end of the barrel near the needle.
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 [email protected] or by phone at +82-54-463-2400
Root Cause
Under Investigation by firm
Distribution Pattern
FL, TN, and VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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