ICU Medical ChemoLock Closed System Transfer Device Packaging Recall
ICU Medical is recalling 6,000 units of ChemoLock Close Vial Spike (Model CL-80) due to incorrect packaging and labeling of finished goods. Units were distributed in Illinois and Canada.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for packaging and labeling errors with no reported injuries, hospitalizations, or illnesses. This fits the 'minor labeling errors' criterion for Moderate severity, as the hazard is documentation-related rather than a functional device defect.
Plain-English summary
ICU Medical, Inc. is recalling 6,000 units of ChemoLock Close Vial Spike (Model CL-80, Lot Number 13959938) because finished goods were incorrectly packaged and labeled.
The ChemoLock Closed System Transfer Device is designed to prevent the transfer of environmental contaminants and to help prevent needlestick injuries and exposure to cytotoxic medications during chemotherapy drug handling. The affected lot was distributed to healthcare facilities in Illinois and Canada.
Healthcare providers and facilities that have received units from this lot should verify the packaging and labeling against the product specifications. Contact ICU Medical for guidance on how to proceed, including information on replacement products.
The recalled product
- Product
- ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytoto
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 6,000
Distribution
Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
FDA (Devices) · 2026-07-22
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
Same hazard · mis labeling
See all →- ModerateAllies Group Recalls Subpotent SPF 50 Sunscreen Gel Sachets
FDA (Drugs) · 2026-09-09
- HighPrince Bakery Recalls Italian and French Bread for Undeclared Sesame
FDA (Food) · 2026-09-09
- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- ModerateWonton Skin Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09
- ModerateWonton Specialist Cooked Noodle Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09