# FDA recall Z-1920-2020

> **ICU Medical, Inc.** · Class II · device recall initiated 2019-10-04.

## Product

REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709059108

## Reason for recall

There is a potential that   IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber.  An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery).  This could result in under-delivery of critical medication which may lead to serious adverse health consequences.

## Distribution

US:AK,AL,AR,AZ,CA,CO,CT,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,SD,TN,TX,UT,VA,WA,WI,WY    OUS: Canada    *** "REF" numbers AH7117 and B30211 were not marketed or distributed within the US***

## Key facts

- **Recall number:** Z-1920-2020
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-04
- **Report date:** 2020-05-13
- **Termination date:** 2021-12-28

- **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-1920-2020

## Citation

> AI Analytics. FDA recall Z-1920-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1920-2020. Source: US FDA. Licensed CC0.

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