Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular a
Summary
The FDA issued a Class II for Trocar Needle - Used for dilating puncture sites or catheter tracts for percutan by Cook Incorporated. Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility.
Details
Source
Device Recall
External ID
Z-1526-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
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
Lot/Code Info: UDI: (01)00827002013773(17) Lot Number: 15786588
Quantity Affected: 55 units
Reason for Recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Distribution
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-01
Company
Bloomington, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cook Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Incorporated have FDA actions?
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1526-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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