Recall Z-1097-2019— ICU Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by ICU Medical, Inc., initiated 2019-02-21, terminated 2024-06-04. FDA's recall record names no specific 510(k) clearance for this event. Product: icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.. Reason: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device..
- Recalling firm
- ICU Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-02-21
- Terminated
- 2024-06-04
- Firm location
- San Clemente, CA, United States
Product description
icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
Reason for recall
There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.