Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Reported: June 15, 2022 Initiated: May 5, 2022 #Z-1240-2022
Product Description
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Reason for Recall
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Details
- Recalling Firm
- Cook Incorporated
- Units Affected
- 106,033
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498). Recalled by Cook Incorporated. Units affected: 106,033.
Why was this product recalled? ▼
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2022. Severity: Moderate. Recall number: Z-1240-2022.
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