| Date Initiated by Firm | August 01, 2005 |
|---|
| Date Posted | September 24, 2005 |
|---|
| Recall Status1 |
Terminated 3 on October 26, 2005 |
| Recall Number | Z-1584-05 |
|---|
| Recall Event ID |
32912 |
| 510(K)Number | K811833 |
|---|
| Product Classification |
Dilator, Urethral - Product Code KOE
|
| Product | Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710. |
|---|
| Code Information |
Lots 15-U1320351 and 15-U1320349. |
| FEI Number |
1825146
|
Recalling Firm/
Manufacturer |
Cook Urological, Inc.
1100 W Morgan St
Spencer
IN
47460-9426
|
| For Additional Information Contact | Tammy Bacon
812-829-4891 |
|---|
Manufacturer Reason
for Recall | Mislabeled as to size. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | The firm advised the hospital customers of the recall by phone on 7/6/05 and asked that the products be returned. One customer was sent a UPS call tag for return of the product and the other customer was requested to refuse receipt of their shipment in transit. |
|---|
| Quantity in Commerce | 3 |
|---|
| Distribution | California and Florida. |
|---|
| 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 = KOE
|
|---|
