Recall Z-1527-2024— Cook Incorporated
Class II · Ongoing
Class II FDA medical device recall by Cook Incorporated, initiated 2024-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490. Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility.
- Recalling firm
- Cook Incorporated
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-01
- Firm location
- Bloomington, IN, United States
Product description
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490
Reason for recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.