Device 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.)
Z-3202-2018
Product summary
- Event
- Event 80944
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,570,800
- Official record key
device-enforcement:Z-3202-2018
Official wording
Reason: Defect consists of a small crack in the top end of the barrel near the needle.
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.
Distribution pattern: FL, TN, and VA
Derived failure modes
-
Unknown
Defect consists of a small crack in the top end of the barrel near the needle.