Kennesaw, GA, United States
CryoLife, Inc. recalls
7 recalls recorded since 2018, most recently on 7 October 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)0
Terminated or completed7
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 October 2021
- Terminated
- 23 October 2023
- Reason
- Product is not approved for use in the EU and should not have been distributed in the EU.
- Distribution
- Distribution in the European Union only (Germany/Switzerland)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0384-2022
- BioGlue Surgical Adhesive, Model BG3510-5-G
Terminated Class II Medical devices
- Recall started
- 10 November 2020
- Terminated
- 26 October 2021
- Reason
- On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
- Distribution
- Distributed nationwide to GA, AZ, TX, MO, and OK.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0652-2021, Z-0653-2021
- CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only with
- CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only wi
Terminated Class II Medical devices
- Recall started
- 17 January 2019
- Terminated
- 9 June 2020
- Reason
- On-X Valve was mislabeled with the incorrect serial number.
- Distribution
- Worldwide Distribution - US Nationwide - Georgia and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1073-2019
- On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aorti
Terminated Class II Medical devices
- Recall started
- 6 September 2018
- Terminated
- 3 March 2020
- Reason
- The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
- Distribution
- US Nationwide in the state of California.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0121-2019
- CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Terminated Class II Medical devices
- Recall started
- 4 June 2018
- Terminated
- 8 February 2019
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2556-2018
- 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 rep
Terminated Class II Medical devices
- Recall started
- 14 May 2018
- Terminated
- 29 March 2019
- Reason
- Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
- Distribution
- AR, OH
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2271-2018, Z-2272-2018
- Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
- Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
Terminated Class II Medical devices
- Recall started
- 21 November 2016
- Terminated
- 24 September 2019
- Reason
- The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
- Distribution
- Product was shipped to Texas
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1219-2019
- CryoPatch SG Pulmonary Hemi-Artery Patch
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.