| Date Initiated by Firm | May 05, 2022 |
|---|
| Create Date | June 06, 2022 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1242-2022 |
|---|
| Recall Event ID |
90103 |
| 510(K)Number | K153778 |
|---|
| Product Classification |
Device, Vascular, for Promoting Embolization - Product Code KRD
|
| Product | Tornado Embolization Microcoil,
RPN GPN
MWCE-18S-5/2-TORNADO G08356
MWCE-18S-6/2-TORNADO G08259
MWCE-18S-3/2-TORNADO-01 G47416
MWCE-18S-4/2-TORNADO-01 G47417
MWCE-18S-3/2-TORNADO-081800 G13102
MWCE-18S-3/2-TORNADO G08261
MWCE-18S-4/2-TORNADO-081800 G13103
MWCE-18S-4/2-TORNADO G08357
MWCE-18S-5/2-TORNADO-01 G47418
MWCE-18S-6/2-TORNADO-01 G47419
MWCE-18S-6/2-TORNADO-081800 G13105
MWCE-18S-5/2-TORNADO-081800 G13104
MWCE-18S-2/4-TORNADO-LEF G09945
MWCE-18S-2/5-TORNADO-LEF-081800 G13108
MWCE-18S-4/3-TORNADO G12924
MWCE-18S-2/3-TORNADO-LEF G09944
MWCE-18S-2/3-TORNADO-LEF-081800 G13106
MWCE-18S-2/4-TORNADO-LEF-081800 G13107 |
|---|
| Code Information |
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(01)00827002083561(17)270316(10)NS14521590
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|
| FEI Number |
1820334
|
Recalling Firm/
Manufacturer |
Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
|
| For Additional Information Contact | Cook Medical Customer Relations Department
800-457-4500 |
|---|
Manufacturer Reason
for Recall | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | On May 5, 2022, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were advised that the presence of a small stainless steel cannula inside the loading cartridge may go undetected by the user.
Customers were instructed to examine their inventory and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. Customers should return the product to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Please share this information with appropriate personnel, down to the user level, within your organization or with any organization where the affected devices may have been transferred.
Physicians should practice their standard patient monitoring following the procedure for an early identification of any complications to mitigate their severity.
If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. |
|---|
| Quantity in Commerce | 106,033 |
|---|
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
|---|
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = KRD
|
|---|
