Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Trans
Summary
The FDA issued a Class II for Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-1 by Cook Incorporated. Reason: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have.
Details
Source
Device Recall
External ID
Z-0994-2026
Action Date
2025-12-31
Status
Ongoing
Category
device
Product Description
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Lot/Code Info: 1) Reference Part Number RTPS-100: Order Number G06541, UDI (01)00827002065413(17)280722(10)16705779, Lot Number 16705779; 2) Reference Part Number RTPS-100-10.0: Order Number G29769, UDI (01)00827002297692(17)280624(10)16659044, Lot Number 16659044
Quantity Affected: 15 units
Reason for Recall
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-26
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 103 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-0994-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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