# FDA recall Z-1347-2018

> **ICU Medical, Inc.** · Class II · device recall initiated 2018-02-05.

## Product

14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx.  The firm name on the label is icumedical, San Clemente, CA.     The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

## Reason for recall

The infusion sets were manufactured with an incorrect spin collar.

## Distribution

Worldwide Distribution: US (nationwide) to state in AZ, CA, CO,  FL, SC, and TX; and countries of: Canada and Japan.

## Key facts

- **Recall number:** Z-1347-2018
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-05
- **Report date:** 2018-04-18
- **Termination date:** 2019-09-17

- **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-1347-2018

## Citation

> AI Analytics. FDA recall Z-1347-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1347-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*