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Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of...

FDA Recall #Z-1526-2024 — Class II — March 1, 2024

Recall #Z-1526-2024 Date: March 1, 2024 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Cook Incorporated — Bloomington, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

55 units

Distribution

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

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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