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Atrium Medical Corporation: Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);

Medical DevicesSource: FDA (device) · Date: 2026-09-16

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Atrium Medical Corporation
Product
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Reason / hazard
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-08-07
Code info
1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;
Product quantity
256
Voluntary mandated
Voluntary: Firm initiated
City
Merrimack
State
NH
Country
United States
Event id
99680
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