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Recall Observatory FDA recall evidence

Device product

Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377

Z-1526-2024

March 01, 2024

Class II

Product summary

Firm
Cook Incorporated
Event
Event 94196
Status
Ongoing
Classification
Class II
Quantity
55 units
Official record key
device-enforcement:Z-1526-2024

Official wording

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

Code information: UDI: (01)00827002013773(17) Lot Number: 15786588

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