Product Description/Item: ChemoLock Vial Spike — Class II medical device recall Z-1682-2022
Ongoing recall by ICU Medical, Inc., reported 2022-09-14, distributed nationwide. Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, d
| Recall number | Z-1682-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2022-06-27 |
| Classified | 2022-09-07 |
| Reported by FDA | 2022-09-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, ES, JP, SA, SI |
| Quantity | 358,975 |
| Lot numbers | 011-CL-51/5850505, 011-CL-80S/5843950, 011-CL4155/5816324, 034-CL-70/5816321, 034-CL-72/5816344, 034-CL2100/5842230, 5829878, 5842209, 5842210, 5850503, 5851021, 5851022, 5872831, 5872840, 5885020, 5910255, 5910258, 5910262, CL-10/5850516, CL-17/5816314, CL3950/5845117, CL3951/5842199, CL3967/5829901, CL4118/5825274, KL-BS001U3/5851020, KL-VA201U3/5819364, KL-VA202U3/5819370, KL-VA321U3/5915973, KL-VA322U3/5920744 |
| Model numbers | 011-CL-80S/5843950 |
Product
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger/CL3951; 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock Port, Clamp, Graduated Adapter/CL3967; 6 IN(15cm)APPX 0.82ml,EXT SET,MicroClave Clear,ChemoLock PORT,YCONN, ROTATING LUER/CL4118; ChemoLock Kit w/ 5" (13 cm) Bag Spike Adapter w/ChemoLock w/Red Cap, Vented Cap, ChemoLock Port Bag Spike/CL4158; ChemosafeLock Bag Spike/KL-BS001U3; ChemosafeLock Vial Adapter/KL-VA201U3; ChemosafeLock Vial Adapter/KL-VA202U3; ChemosafeLock Vial Adapter/KL-VA321U3; ChemosafeLock Vial Adapter/KL-VA322U3; ChemoLock Vented Vial Spike/011-CL-51; Transfer Set, PUR Yellow w/ChemoLock Port, Spiros/011-CL4155; Puerto ChemoLock/034-CL2100; ChemoLock, Punzon Univ. Vial c/ Filtro, fijacion/034-CL-70; ChemoLock, Punzon Vial Tritan c/ Filtro, 13mm/034-CL-72
Reason for recall
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1682-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.