# FDA recall Z-0197-2021

> **ICU Medical, Inc.** · Class II · device recall initiated 2020-07-06.

## Product

7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer;  unit per pouch, 50 multivac pouches per case. UDI:(01)10887709088190(17)241201(30)50(10)4515232;(01)10887709068350(17)250101(30)50(10)4572761    The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices.

## Reason for recall

Identification of a  potential  manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

## Distribution

Worldwide Distribution: US (nationwide): AL, AZ, CA, CO, DE, FL,GA,ID, IL,IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH,NJ,NM,NV, NY, OH, OK, OR, PA,RI, TN, TX, UT, VA, WA, WI, and WV; and OUS countries of: Belgium, Brazil, Canada, France, Germany, Ireland, Japan, Martinique, Mexico, Poland, and Saudi Arabia.

## Key facts

- **Recall number:** Z-0197-2021
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-06
- **Report date:** 2020-10-28
- **Termination date:** 2023-05-11

- **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-0197-2021

## Citation

> AI Analytics. FDA recall Z-0197-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0197-2021. Source: US FDA. Licensed CC0.

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