Z-2271-2018 Class II Terminated
FDA device recall Z-2271-2018 was initiated by CryoLife, Inc. on May 14, 2018 and is designated Class II. Reason for recall: Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. The recall status is terminated (terminated March 29, 2019). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2018
- Initiation Date
- May 14, 2018
- Termination Date
- March 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Reason for Recall
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
Distribution Pattern
AR, OH
Code Information
Serial Number 10988203