| Date Initiated by Firm | August 16, 2022 |
|---|
| Date Posted | September 28, 2022 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1837-2022 |
|---|
| Recall Event ID |
90793 |
| 510(K)Number | K082536 |
|---|
| Product Classification |
Endoscopic guidewire, gastroenterology-urology - Product Code OCY
|
| Product | Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire
Reference Part Number/GPN:
RPC-035145-0-5 G34131
RPC-035145 G18154
RPC-035145-5 G34132
RPC-038145-0-5 G34129
RFSPC-038145-0 G17539
RFSPC-035145 G17540
RPC-038145-0 G18155
RPC-035145-0 G18153
RFSPC-035145-0 G17542 |
|---|
| Code Information |
RPC-035145-0-5 G34131
UDI-DI: 00827002341319
Lot/Expiration Date:
14769270X 03-06-2025
14802181 20-06-2025
14816224 28-06-2025
14818488 29-06-2025
14818489 29-06-2025
14828627 06-07-2025
14828629 06-07-2025
RPC-035145 G18154
UDI-DI: 00827002181540
Lot/Expiration Date:
14770863 06-06-2025
14770864 06-06-2025
14813490 27-06-2025
14816227 28-06-2025
NS14770866 06-06-2025
NS14804982 21-06-2025
RPC-035145-5 G34132
UDI-DI: 00827002341326
Lot/Expiration Date:
14770872 06-06-2025
14810022 23-06-2025
14831440 07-07-2025
RPC-038145-0-5 G34129
UDI-DI: 00827002341296
Lot/Expiration Date:
14804972 21-06-2025
14809971 23-06-2025
RFSPC-038145-0 G17539
UDI-DI: 00827002175396
Lot/Expiration Date:
14809157 23-06-2025
14837048 12-07-2025
RFSPC-035145 G17540
UDI-DI: 00827002175402
Lot/Expiration Date:
14818484 29-06-2025
14818485 29-06-2025
14818490 29-06-2025
14840310 13-07-2025
RPC-038145-0 G18155
UDI-DI: 00827002181557
Lot/Expiration Date:
14819269 29-06-2025
14823406 01-07-2025
14832976 08-07-2025
NS14828649 06-07-2025
RPC-035145-0 G18153
UDI-DI: 00827002181533
Lot/Expiration Date:
14828625 06-07-2025
14828630 06-07-2025
14828635 06-07-2025
14828636 06-07-2025
14828637 06-07-2025
14828640 06-07-2025
14828641 06-07-2025
14841469 14-07-2025
NS14813479 27-06-2025
NS14818486 29-06-2025
RFSPC-035145-0 G17542
UDI-DI: 00827002175426
Lot/Expiration Date:
14844152 15-07-2025 |
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 | 56 US; 1033 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.
|
| 510(K) Database | 510(K)s with Product Code = OCY
|
|---|
