Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
Reported: December 29, 2021 Initiated: October 13, 2021 #Z-0414-2022
Product Description
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
Reason for Recall
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 112 US, 240 OUS
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA and the countries of France, Italy, and Mexico.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.. Recalled by Cook Inc.. Units affected: 112 US, 240 OUS.
Why was this product recalled? ▼
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 29, 2021. Severity: Moderate. Recall number: Z-0414-2022.
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