Device product
Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
Z-2535-2026
Product summary
- Event
- Event 99162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 270 kits
- Official record key
device-enforcement:Z-2535-2026
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) DYNJRA1590, UDI-DI: 10193489284829(each), 40193489284820(case), Lot Number: 25JLA522
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.