Reported Sep 16, 2026 · Ongoing
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3.…
Atrium Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atrium Medical Corporation · 40 Continental Blvd · Merrimack, NH · 03054-4332
Is this the product you have?
- Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case
- Size(Model Number)
1. 16FR(8016)2. 24FR(8024)3. 28FR(8028)4. 32FR(8032)5. 36FR(8036)
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 00650862130164Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878 2 00650862130249Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835 3 00650862130287Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681 4 00650862130324Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840 5 00650862130362Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686 - Amount recalled
- 3618
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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