Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
Reported: October 5, 2022 Initiated: August 16, 2022 #Z-1836-2022
Product Description
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
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.
Details
- Recalling Firm
- Cook Incorporated
- Units Affected
- 42 US
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561. Recalled by Cook Incorporated. Units affected: 42 US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2022. Severity: Moderate. Recall number: Z-1836-2022.
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