Device product
Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
Z-2538-2026
Product summary
- Event
- Event 99162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 510 kits
- Official record key
device-enforcement:Z-2538-2026
Official wording
Reason: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Code information: 1) I550BF6C, UDI-DI: 10653160339748(each), 00653160339741(case), Lot Number: 2025102290; 2) I505BF9C, UDI-DI: 10653160339687(each), 00653160339680(case), Lot Number: 2025093090
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.