Product Description/Item: ChemoLock Bag Spike — Class II medical device recall Z-1681-2022
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-1681-2022 |
|---|---|
| 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 | 454,635 |
| UPC / GTIN / UDI-DI | 10840619080577, 10887709056975, 10887709056982, 10887709057019, 10887709057026, 10887709057040, 10887709057088, 10887709057095, 10887709057125, 10887709062440, 10887709067155, 10887709069593, 10887709069630, 10887709069777, 10887709070988, 10887709070995, 10887709071022, 10887709071411, 10887709071909, 10887709073408, 10887709075440, 10887709077116, 10887709080291, 10887709080307, 10887709080413 and 24 more |
| Lot numbers | 5782864, 5816306, 5816310, 5816312, 5816315, 5816334, 5816356, 5816379, 5825248, 5829020, 5829021, 5829022, 5829023, 5829024, 5829875, 5829882, 5841980, 5841982, 5841994, 5842200, 5842216, 5842218, 5842227, 5842229, 5845354, 5849474, 5849630, 5849631, 5849632, 5849713, 5849714, 5849715, 5849716, 5849740, 5849748, 5850497, 5850499, 5850507, 5850510, 5850512 and 65 more |
Product
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike w ChemoLock Port/CL2150; 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger/CL3011; 9 IN(23cm)APPX 2.7ml,EXT SET,ChemoLock PORT,2 CLAMPS,2 GRADUATED CONN/CL3364; Syringe Transfer Set w Clave, ChemoLock Port/CL-34; 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, ChemoLock w Red Cap, Bag Hanger/CL3511; 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, ChemoLock w Red Cap, Bag Hanger/CL3511T; 30" (76cm) Appx 6.3 ml, 20 Drop Admin Set w Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock w Red Cap, Hanger/CL3528; 7" (18 cm) Appx .93 ml, Ext Set w/ChemoLock, Y-Connector, Rotating Luer/CL3535T; Oncology Kit w/5" (13 cm) Add-On Set w ChemoLock Additive Port, Vented Cap, ChemoLock, Spinning Spiros w Red Cap/CL3538; Graduated Connector w ChemoLock Port/CL3900; ONCOLOGY KIT, EXT,ChemoLock PORT, GRAD CONN,TRANSFER,ChemoLock,VIAL SPIKE,ChemoLock PORT/CL3927; Oncology Kit w 5" (13 cm) Add-On Set w ChemoLock w Red Cap, Vented Cap, ChemoLock Port w Bag Spike, Spiros w Red Cap/CL3946; Oncology Kit w 17" (43 cm) Bifuse Ext Set w/ChemoLock w Red Cap, ChemoLock Port, ChemoLock Vented Vial Spike, 13mm ChemoLock/CL3947; Oncology Kit w ChemoLock Port Closed Vial Spike, ChemoLock, ChemoLock Port Bag Spike/CL3952; APPX 0.5ml, ChemoLock BAG SPIKE WITH ADDITIVE PORT,ChemoLock Port/CL3955;
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-1681-2022. 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.