| Date Initiated by Firm | August 16, 2022 |
|---|
| Date Posted | September 28, 2022 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1844-2022 |
|---|
| Recall Event ID |
90793 |
| Product Classification |
Connector, catheter - Product Code GCD
|
| Product | Vinyl Connecting Tube, Connecting Tube
Reference Part Number/GPN
CTU14.0-30-ST G02278
CTU14.0-40-ST G02327
CTU14.0-30 G02791
CTU14.0-50-ST G02464
C-CTU14.0-30-ST G02898 |
|---|
| Code Information |
CTU14.0-30-ST G02278
UDI-DI: 00827002022782
Lots/Expiration Date:
14806993 22-06-2025
14806994 22-06-2025
14806997 22-06-2025
14807003 22-06-2025
14809136 23-06-2025
14809138 23-06-2025
14809140 23-06-2025
14809141 23-06-2025
14811461 24-06-2025
14823426 01-07-2025
14823427 01-07-2025
14823428 01-07-2025
14823429 01-07-2025
14826334 05-07-2025
14826335 05-07-2025
14826337 05-07-2025
14826338 05-07-2025
14831013 07-07-2025
14831014 07-07-2025
14832846 08-07-2025
14833913 08-07-2025
14834825 11-07-2025
14835074 11-07-2025
14835079 11-07-2025
14835400 11-07-2025
14835401 11-07-2025
14836968 12-07-2025
14836973 12-07-2025
14836974 12-07-2025
14836975 12-07-2025
14841346 14-07-2025
14844979 18-07-2025
14844980 18-07-2025
14844981 18-07-2025
14844983 18-07-2025
14844984 18-07-2025
14847734 19-07-2025
14847738 19-07-2025
NS14809137 23-06-2025
NS14832847 08-07-2025
CTU14.0-40-ST G02327
UDI-DI: 00827002023277
Lots/Expiration Date:
14811457 24-06-2025
14811459 24-06-2025
14811460 24-06-2025
14821325 30-06-2025
14821326 30-06-2025
14826333 05-07-2025
14831010 07-07-2025
14832848 08-07-2025
14835078 11-07-2025
14847740 19-07-2025
NS14818298 29-06-2025
CTU14.0-30 G02791
UDI-DI: 00827002027916
Lots/Expiration Dates:
14816266 28-06-2025
14816268 28-06-2025
14816269 28-06-2025
14816273 28-06-2025
14834821 11-07-2025
14835076 11-07-2025
14835077 11-07-2025
14841348 14-07-2025
14841352 14-07-2025
14847735 19-07-2025
NS14816264 28-06-2025
NS14816265 28-06-2025
NS14831012 07-07-2025
NS14851689 21-07-2025
CTU14.0-50-ST G02464
UDI-DI: 00827002024649
Lots/Expiration Date:
14816271 28-06-2025
14831009 07-07-2025
NS14813459 27-06-2025
NS14826331 05-07-2025
NS14826336 05-07-2025
NS14841345 14-07-2025
C-CTU14.0-30-ST G02898
UDI-DI: 00827002028982
Lots/Expiration Date:
14826332 05-07-2025
NS14816270 28-06-2025 |
| 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 | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit.
If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235 |
|---|
| Quantity in Commerce | 240 US; 108 OUS |
|---|
| 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.
|
