Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3.
Summary
The FDA issued a Class II for Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Nu by Atrium Medical Corporation. Reason: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters..
Details
Source
Device Recall
External ID
Z-3112-2026
Action Date
2026-09-16
Status
Ongoing
Category
device
Product Description
Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
Lot/Code Info: 1. Model Number(Size): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852; 2. Model Number(Size): 8128(28FR); UDI-DI: 00650862132281; Lot Number: ME244854, ME244855; 3. Model Number(Size): 8132(32FR); UDI-DI: 00650862132328; Lot Numbers: ME244565, ME244858, ME244859; 4. Model Number(Size): 8136(36FR); UDI-DI: 00650862132366; Lot Number: ME244861;
Quantity Affected: 2533
Reason for Recall
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-07
Company
Merrimack, NH
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 180 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Atrium Medical Corporation has 88 FDA actions in our database, including 87 recalls and 1 clearance.
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 (Atrium Medical Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Atrium Medical Corporation have FDA actions?
Atrium Medical Corporation has 88 FDA actions in our database, including 87 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3112-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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