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Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 sy...

FDA Device Recall #Z-3202-2018 — Class II — August 24, 2018

Recall Summary

Recall Number Z-3202-2018
Classification Class II — Moderate risk
Date Initiated August 24, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ShinChang Medical Co., Ltd.
Location Gumi, N/A
Product Type Devices
Quantity 6,570,800

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.

Distribution Pattern

FL, TN, and VA

Lot / Code Information

GNP Insulin Syringe 0.3mL 31G¿5/16" NP18127, Healthmart Insulin Syringe 0.3mL 31G¿5/16" NP18155, Healthmart Insulin Syringe 0.3mL 31G¿5/16" NP18186, Kroger Insulin Syringe 0.3mL 30G¿5/16" NP18082, Kroger Insulin Syringe 0.3mL 31G¿5/16" NP18083, Kroger Insulin Syringe 0.3mL 30G¿5/16" NP18126, Kroger Insulin Syringe 0.3mL 30G¿5/16" NP18146, Kroger Insulin Syringe 0.3mL 31G¿5/16" NP18157, Leader Insulin Syringe 0.3mL 31G¿5/16" NP18123, Leader Insulin Syringe 0.3mL 31G¿5/16" NP18130, Leader Insulin Syringe 0.3mL 30G¿5/16" NP18151, Leader Insulin Syringe 0.3mL 31G¿5/16" NP18161, Leader Insulin Syringe 0.3mL 30G¿5/16" NP18180, Leader Insulin Syringe 0.3mL 31G¿5/16" NP18202, Nipro Insulin Syringe 0.3mL 31G¿5/16" NP18125. Nipro Insulin Syringe 0.3mL 30G¿5/16" NP18129. Nipro Insulin Syringe 0.3mL 31G¿5/16" NP18142. Nipro Insulin Syringe 0.3mL 31G¿5/16" NP18170. Nipro Insulin Syringe 0.3mL 29G¿1/2" NP18196. Nipro Insulin Syringe 0.3mL 30G¿5/16" NP18197. Nipro Insulin Syringe 0.3mL 30G¿5/16" NP18199. Sunmark Insulin Syringe 0.3mL 31G¿5/16" NP18124, Sunmark Insulin Syringe 0.3mL 30G¿5/16" NP18128, Sunmark Insulin Syringe 0.3mL 31G¿5/16" NP18136, Sunmark Insulin Syringe 0.3mL 31G¿5/16" NP18166, Sunmark Insulin Syringe 0.3mL 30G¿5/16" NP18206, Lite Touch Insulin Syringe 0.3mL 30G¿5/16" LT1805, and McKesson Insulin Syringe 0.3mL 31G¿5/16" KSH0603.

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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