# FDA recall Z-1682-2022

> **ICU Medical, Inc.** · Class II · device recall initiated 2022-06-27.

## 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/0

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of LA, FL, TX, NY, NE, WI, PA, IA, ND, CA, OH, WA, GA, AL, CO, AZ, NC, TN, MI, VA, MA, DE, OR, KY, CT, OK, NJ, MN, IL, VT, AR, RI, ID, IN, UT, NV, MT, MD, KS, SC, NM, ME, MO, SD and the countries of : Saudi Arabia, Australia, United Arab Emirates, Spain, Slovenia, Japan, Canada.

## Key facts

- **Recall number:** Z-1682-2022
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-27
- **Report date:** 2022-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Clemente, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1682-2022

## Citation

> AI Analytics. FDA recall Z-1682-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1682-2022. Source: US FDA. Licensed CC0.

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