# FDA recall Z-1681-2022

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

## 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 Se

## 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-1681-2022
- **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-1681-2022

## Citation

> AI Analytics. FDA recall Z-1681-2022. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1681-2022. Source: US FDA. Licensed CC0.

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