# FDA recall Z-2556-2018

> **CryoLife, Inc.** · Class II · device recall initiated 2018-06-04.

## Product

BioGlue Spreader Tip, 12mm, Sterile, RX Only.    Product Usage:  BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).

## Reason for recall

The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.

## Distribution

Distribution is to Japan

## Key facts

- **Recall number:** Z-2556-2018
- **Recalling firm:** CryoLife, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-04
- **Report date:** 2018-08-01
- **Termination date:** 2019-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kennesaw, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2556-2018

## Citation

> AI Analytics. FDA recall Z-2556-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2556-2018. Source: US FDA. Licensed CC0.

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