| Date Initiated by Firm | May 05, 2022 |
|---|
| Create Date | June 06, 2022 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1240-2022 |
|---|
| Recall Event ID |
90103 |
| 510(K)Number | K160219 |
|---|
| Product Classification |
Device, Vascular, for Promoting Embolization - Product Code KRD
|
| Product | Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498) |
|---|
| Code Information |
Lots:
14212811
14215685
14212247
14212812
14212814
14215682
14361413
14361416
14285326
14285328
14285330
14297289
14361412
14445407
14444454
14477949
14477950
UDI:
(01)00827002474994(17)261013(10)14212811
(01)00827002474994(17)261008(10)14215685
(01)00827002474987(17)261011(10)14212247
(01)00827002474987(17)261008(10)14212812
(01)00827002474994(17)261008(10)14212814
(01)00827002474994(17)261008(10)14215682
(01)00827002474994(17)261219(10)14361413
(01)00827002474994(17)261220(10)14361416
(01)00827002474987(17)261110(10)14285326
(01)00827002474987(17)261110(10)14285328
(01)00827002474994(17)261110(10)14285330
(01)00827002474994(17)261123(10)14297289
(01)00827002474987(17)261220(10)14361412
(01)00827002474987(17)270207(10)14445407
(01)00827002474994(17)270207(10)14444454
(01)00827002474987(17)270217(10)14477949
(01)00827002474994(17)270216(10)14477950
|
| 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
|
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