# FDA recall Z-0106-2018

> **ICU Medical, Inc.** · Class II · device recall initiated 2017-08-31.

## Product

SURPLUG MICRO CONNECTOR Item No. 066-C3352;   111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167;   32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243;   10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer Item No. B33084;   3-Way High Flow Stopcock w/Rotating Luer Item No. B4020;   38" Non-DEHP Smallbore Ext Set w/2 T-Connectors/Inj Sites, Remv 3-Way Stopcock, 2 Clamps, Luer Slip Item No. B4054;   300" Ext Set w/Remv 3-Way Stopcock, Check Valve, Clamp, Rotating Luer Item No. B4121;   3 Gang 3-Way Stopcocks w/Rotating Luer Item No. B4154;   33" Ext Set w/Remv 3-Way Stopcock, Luer Lock Item No. B4171;   35" (89 cm) Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B4181;   113" 15 Drop Primary Set w/2 MicroClave, Remv 3 Gang Manifold w/2 1o2, 3 Way Stopcock, Rotating Luer, 1 Ext Item No. B5153;   131" (333 cm) Appx 17.2 mL, 20 Drop Admin Set w/4 Pre-slit Ports, MicroClave, Remv 3-Way Stopcock,

## Reason for recall

ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.

## Distribution

US Distribution and Internationally to TH.

## Key facts

- **Recall number:** Z-0106-2018
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-31
- **Report date:** 2017-11-29
- **Termination date:** 2018-10-17

- **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-0106-2018

## Citation

> AI Analytics. FDA recall Z-0106-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0106-2018. Source: US FDA. Licensed CC0.

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