| | Class 2 Device Recall |  |
| Date Initiated by Firm | May 06, 2004 |
|---|
| Date Posted | November 03, 2004 |
|---|
| Recall Status1 |
Terminated 3 on June 29, 2010 |
| Recall Number | Z-0169-05 |
|---|
| Recall Event ID |
30218 |
| Product Classification |
Heart-Valve, Allograft - Product Code MIE
|
| Product | CryoValve, Pulmonary Valve and Conduit - SG |
|---|
| Code Information |
Donor #55634, Serial #7250375, Model #SGPV00* Donor #60740, Serial #7756769, Model #SGPV00* Donor #60758, Serial #7765469, Model #SGPV00* Donor #60760, Serial #7753955, Model #SGPV00* Donor #63969, Serial #7907208, Model #SGPV00* Donor #64863, Serial #7865589, Model #SGPV00 |
Recalling Firm/
Manufacturer |
Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
|
| For Additional Information Contact | Mr. P. Tyler Cochran, CQA, CTBS
770-419-3355 |
|---|
Manufacturer Reason
for Recall | CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified by letter on/about May 6, 2004. |
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| Quantity in Commerce | 6 units |
|---|
| Distribution | Nationwide, Austria, Canada, Germany |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
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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.
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