Device recall: Pulmonary Hemi-Artery SG Used in heart surgery

FDA enforcement event 67182 · Class II · initiated 22 Nov 2013 · status Terminated · terminated 20 Feb 2014

DeviceVoluntary: Firm initiated1 product recordKennesaw, GA

FDA enforcement event 67182 is a device recall by CryoLife, Inc. of Kennesaw, GA, initiated 22 Nov 2013 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 20 Feb 2014. Initiation: voluntary: firm initiated. CryoLife, Inc. has 12 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

CryoLife, Inc., Kennesaw, GA.

Reason for recall

"Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death."

Distribution

"US distribution in CA."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0809-2014	Pulmonary Hemi-Artery SG Used in heart surgery	One	Class II	Terminated	29 Jan 2014

Context

90%of 2013 device events are Class II1,236 events that year

1product record in this eventfirm median: 1

12events on this register for the firm

Other enforcement events for CryoLife, Inc.

Initiated	Product (first record)	Type	Class	Records
7 Oct 2021	BioGlue Surgical Adhesive, Model BG3510-5-G	Device	Class II	1
10 Nov 2020	CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectan	Device	Class II	2
17 Jan 2019	On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the re	Device	Class II	1
6 Sep 2018	CryoPatch SG Pulmonary Hemi-Artery, 1 graft	Device	Class II	1
4 Jun 2018	BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard meth	Device	Class II	1
14 May 2018	Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO	Device	Class II	2
19 May 2017	BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J	Device	Class II	1
21 Nov 2016	CryoPatch SG Pulmonary Hemi-Artery Patch	Device	Class II	1
12 Jun 2015	On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native	Device	Class II	1
25 Apr 2014	BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to sta	Device	Class II	1

All 12 events for CryoLife, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US distribution in CA."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 20 Feb 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.