FDA DevicesClass II
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Cla...
Published: May 27, 2026Recall ID: Z-2210-2026Category: devicesCountry: US
Reason for Recall / Hazard
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
Product Description & Identification
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
Additional Source Details
| Field | Value |
|---|---|
| City | San Clemente |
| State | CA |
| Event id | 98622 |
| Address 1 | 951 Calle Amanecer |
| Code info | UDI-DI: 10887709083278. Lots: 13919794, 14134777, 14196319 |
| Postal code | 92673-6212 |
| Report date | 20260527 |
| Product type | Devices |
| Product quantity | 20,506 |
| Reason for recall | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260324 |
| Center classification date | 20260518 |
Overview
- Recalling FirmICU Medical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ.