| Date Initiated by Firm | May 14, 2018 |
|---|
| Create Date | June 21, 2018 |
|---|
| Recall Status1 |
Terminated 3 on March 29, 2019 |
| Recall Number | Z-2271-2018 |
|---|
| Recall Event ID |
80199 |
| 510(K)Number | K092021 |
|---|
| Product Classification |
Heart valve, more than minimally manipulated allograft - Product Code OHA
|
| Product | Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO |
|---|
| Code Information |
Serial Number 10988203 |
Recalling Firm/
Manufacturer |
CryoLife, Inc.
1655 Roberts Blvd NW
Kennesaw GA 30144-3632
|
| For Additional Information Contact |
770-419-3355 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | The firm notified the consignees by letter on 05/14/2018. |
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| Quantity in Commerce | 1 unit |
|---|
| Distribution | AR, OH |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = OHA
|
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