# FDA recall Z-0141-2020

> **ICU Medical Inc** · Class II · device recall initiated 2019-07-29.

## Product

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL.  1 unit per pouch;  1 unit per blister; 40 blisters per case .  Not distributed in the U.S.

## Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

## Distribution

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.      International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-0141-2020
- **Recalling firm:** ICU Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-29
- **Report date:** 2019-10-23
- **Termination date:** 2024-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0141-2020

## Citation

> AI Analytics. FDA recall Z-0141-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-0141-2020. Source: US FDA. Licensed CC0.

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