Recall Z-0414-2022— Cook Inc.
Class II · Ongoing
Class II FDA medical device recall by Cook Inc., initiated 2021-10-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-10-13
- Firm location
- Bloomington, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.