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Recall Observatory FDA recall evidence

Device 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

Z-1527-2024

March 01, 2024

Class II

Product summary

Firm
Cook Incorporated
Event
Event 94196
Status
Ongoing
Classification
Class II
Quantity
296 units
Official record key
device-enforcement:Z-1527-2024

Official wording

Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

Code information: UDI: (01)00827002094901(17) Lot Number: 15787864, 15804398

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility