FDA DevicesClass II
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Published: January 14, 2026Recall ID: Z-1010-2026Category: devicesCountry: US
Reason for Recall / Hazard
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Product Description & Identification
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Affected Products
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Additional Source Details
| Field | Value |
|---|---|
| City | Rancho Santa Margarita |
| State | CA |
| Event id | 98191 |
| Address 1 | 22872 Avenida Empresa |
| Code info | UDI: (01)00607915126582; Lot # 1546141 |
| Postal code | 92688-2650 |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | 450 units |
| Reason for recall | There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251211 |
| Initial firm notification | Letter |
| Center classification date | 20260102 |
Overview
- Recalling FirmApplied Medical Resources Corp
- StatusOngoing
- Risk LevelClass II
- DistributionUS: MI, CA, ME, OUS: France Great Britain, Germany