Z-2556-2018Class II

BioGlue Spreader Tip, 12mm, Sterile, RX Only

Name: Z-2556-2018 BioGlue Spreader Tip, 12mm, Sterile, RX Only
Creator: CryoLife, Inc.
Published: 2018-06-04
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2018-06-04 / Terminated / root cause: labeling and UDI

FDA source

CryoLife, Inc. began a recall of 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... on 2018-06-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2556-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-04
Posted: 2018-07-26
Terminated: 2019-02-08
Recalling firm: Artivion, Inc.
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).
Product code: MUQ Glue, Surgical, 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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: CyroLife notified their customers on/about 06/04/2018 via Urgent - Important Product Removal letter. instructions indicated that affected pouches have been returned to CryoLife, Inc. Any questions/clarifications regarding this removal are directed to contact 800-438-8285 or by email to fieldassurance@c ryolife.com.
Quantity in commerce: 855 Total
Distribution: Distribution is to Japan
Product codes and lots: Model Number BG3510-5-J, Lot Number 18MJX002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2556-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2556-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-26

Product code MUQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)