FDA DevicesClass II
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
Published: July 8, 2026Recall ID: Z-2540-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
Affected Products
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 99162 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | 1) SUT13710, UDI-DI: 00653160148527(each), 10653160148524(case), Lot Number: 2025102290 |
| Postal code | 60093-2753 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 176 kits |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260521 |
| Initial firm notification | Letter |
| Center classification date | 20260629 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.