Cryopatch Sg Pulmonary Human Cardiac Patch

• • Terminated Z-0653-2021 FDA Class II ·initiated 10 Nov 2020

  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.

• • Terminated Z-2272-2018 FDA Class II ·initiated 14 May 2018

  Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.

• • Terminated Z-0809-2014 FDA Class II ·initiated 22 Nov 2013

  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.

• • Terminated Z-1561-2011 FDA Unclassified (pre-2012) ·initiated 17 Feb 2011

  Staphylococcus aureus (not methicillin resistant) identified in companion tissue.

510(k) Number

K101866 ↗

FDA Product Code

DXZ

Device Class

Class II

Regulation

21 CFR Part 870.3470

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• PhotoFix Decellularized Bovine Pericardium

  Class II

  FDA 510(k) K183635 Active Cleared 14 Feb 2019

• Cryovalve Sg Pulmonary Human Heart Valve (and Conduit) Open recall

  Unclassified

  FDA 510(k) K092021 Active Cleared 25 May 2010

• Cryopatch Sg Pulmonary Hemi-Artery; Trunk; Branch Open recall

  Class II

  FDA 510(k) K091626 Active Cleared 7 Aug 2009

• Perclot Topical

  Unclassified

  FDA 510(k) K132105 Active Cleared 3 Apr 2014

• Propatch Soft Tissue Repair Matrix

  Class II

  FDA 510(k) K061892 Active Cleared 22 Nov 2006

• Human Heart Valve, Cryovalve Sg

  Unclassified

  FDA 510(k) K033484 Active Cleared 7 Feb 2008

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