FDAFDA · Food and drugs·Recall number Z-1526-2024
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
Published April 24, 2024 · Recall initiated: March 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Incorporated
- Distributor
- Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
- Lot
- UDI: (01)00827002013773(17) Lot Number: 15786588
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.