Device product
Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A
Z-2545-2026
Product summary
- Event
- Event 99162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 432 kits
- Official record key
device-enforcement:Z-2545-2026
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) PAIN1699A, UDI-DI: 10195327411107(each), 40195327411108(case), Lot Number: 25JLA719
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.