FDA Device recall Z-0805-2019
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental c…
- FDA Device
- Class I
- terminated
- Published 2019-03-06
On 2019-03-06 the FDA classified a Class I recall of icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental c… by Icu Medical, citing there is a potential for one lot of ChemoLock Vial Spike to contain burr particulate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0805-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-01-03 |
| Published | 2019-03-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Icu Medical |
| Distribution | CA, FL, IA, IL, OH, PA, VA |
Product
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S 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.
Reason
There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
Identifiers
| code_info | Lot Number 3757712 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0805-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.