FDAFDA · Food and drugs·Recall number Z-3111-2026
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);
Published September 16, 2026 · Recall initiated: August 7, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Atrium Medical Corporation
- Distributor
- US Nationwide distribution.
- Lot
- 1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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