Cook Centesis Catheter Needle recalled for packaging seal defect
Cook Incorporated recalled the Yueh Centesis Disposable Catheter Needle due to packaging with low seal strength that may compromise device sterility. The recall affects 296 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a medical device intended for invasive procedures. While no illnesses or injuries have been reported, compromised device sterility represents a significant risk of harm during invasive procedures such as paracentesis and thoracentesis.
Plain-English summary
Cook Incorporated has recalled the Yueh Centesis Disposable Catheter Needle (Reference Part Number DTVN-5.0-19-10.0-YUEH, Order Number G09490), a medical device used for percutaneous fluid aspirations including paracentesis and thoracentesis procedures.
The recall was initiated because packaging may have low seal strength and may not meet required peel strength specifications. This packaging defect could compromise the device's sterility, which is critical for medical devices used in invasive procedures.
A total of 296 units have been recalled. The affected devices were distributed worldwide, including throughout the United States and in the following countries: Austria, Australia, Brazil, Canada, Switzerland, Germany, Spain, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, New Zealand, and Singapore. The affected lot numbers are 15787864 and 15804398.
If you have received or used this device, contact Cook Incorporated immediately for replacement or return instructions.
The recalled product
- 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
- Manufacturer
- Cook Incorporated
- Affected units
- 296
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: (01)00827002094901(17) Lot Number: 15787864
- 15804398
Distribution
Part of a larger recall action
This product is one of 8 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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