Z-1093-2019 Class I Terminated
FDA device recall Z-1093-2019 was initiated by ICU Medical, Inc. on February 21, 2019 and is designated Class I. 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. The recall status is terminated (terminated June 4, 2024). Affected quantity: 60500 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- February 21, 2019
- Termination Date
- June 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60500 devices
Product Description
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.
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.
Distribution Pattern
Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
Code Information
Lot Numbers: 3826647, 3826648, 3826844, 3827598, 3839689, 3839690, 3854000, 3854001, 3866761, 3873006, 3936065, 3952512