# FDA recall Z-2559-2018

> **Galt Medical Corporation** · Class II · device recall initiated 2018-05-02.

## Product

1) Vascular Dilator,  Sterile EO, Rx Only, Catalog #: DIL-100-12;    2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11;    3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14;    4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14;    5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04;    6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11;    7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12;    8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02;    9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88    10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;

## Reason for recall

The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

## Distribution

U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY,  NC, and Puerto Rico;    OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea

## Key facts

- **Recall number:** Z-2559-2018
- **Recalling firm:** Galt Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-02
- **Report date:** 2018-08-08
- **Termination date:** 2020-07-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Garland, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2559-2018

## Citation

> AI Analytics. FDA recall Z-2559-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2559-2018. Source: US FDA. Licensed CC0.

---

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