| Date Initiated by Firm | December 13, 2010 |
|---|
| Date Posted | January 25, 2011 |
|---|
| Recall Status1 |
Terminated 3 on January 31, 2011 |
| Recall Number | Z-0966-2011 |
|---|
| Recall Event ID |
57708 |
| 510(K)Number | K820313 |
|---|
| Product Classification |
urological device - Product Code KOD
|
| Product | Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050. |
|---|
| Code Information |
U1973244 |
| FEI Number |
1825146
|
Recalling Firm/
Manufacturer |
Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN
1100 W Morgan St
Spencer IN 47460-9426
|
| For Additional Information Contact | Julie Cooper
812-829-4891 |
|---|
Manufacturer Reason
for Recall | The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch. |
|---|
FDA Determined
Cause 2 | Packaging process control |
|---|
| Action | The firm sent an URGENT RECALL NOTICE to one consignee on 12/13/2010 (the other consignee returned all their product as a complaint). The letter informed the consignee of the recall and asked the customer to return the recalled product. |
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| Quantity in Commerce | 25 stents |
|---|
| Distribution | CA, CT |
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| 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 = KOD
|
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