FDA Device recall Z-1527-2024
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis by Cook, citing packaging may have low seal strength and not meet peel strength specifications, compromising device sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1527-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-01 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook |
| Distribution | US |
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
Identifiers
| code_info | UDI: (01)00827002094901(17) Lot Number: 15787864, 15804398 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1527-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.