Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
FDA device recall Z-1838-2022 · posted 2022-09-28 · Open, Classified
Recall details
- Recalling firm
- Cook Incorporated
- 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.
- Action taken
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DQX
- Quantity affected
- 277 US; 138 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Date initiated
- 2022-08-16
- Date posted
- 2022-09-28
- Location
- Bloomington, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Roadrunner PC Wire Guide, Olcott Torque Device (K182985) | Cook Incorporated | 2019-07-22 |